id	sid	tid	token	lemma	pos
globalce-157	1	1	5	5	NUM
globalce-157	1	2	j	j	PROPN
globalce-157	1	3	global	global	ADJ
globalce-157	1	4	clinical	clinical	ADJ
globalce-157	1	5	engineering	engineering	PROPN
globalce-157	1	6	vol.6	vol.6	PROPN
globalce-157	1	7	issue	issue	NOUN
globalce-157	1	8	1	1	NUM
globalce-157	1	9	:	:	PUNCT
globalce-157	1	10	2023	2023	NUM
globalce-157	1	11	received	receive	VERB
globalce-157	1	12	may	may	PROPN
globalce-157	1	13	5	5	NUM
globalce-157	1	14	,	,	PUNCT
globalce-157	1	15	2023	2023	NUM
globalce-157	1	16	,	,	PUNCT
globalce-157	1	17	accepted	accept	VERB
globalce-157	1	18	october	october	PROPN
globalce-157	1	19	3	3	NUM
globalce-157	1	20	,	,	PUNCT
globalce-157	1	21	2023	2023	NUM
globalce-157	1	22	,	,	PUNCT
globalce-157	1	23	date	date	NOUN
globalce-157	1	24	of	of	ADP
globalce-157	1	25	publication	publication	NOUN
globalce-157	1	26	november	november	PROPN
globalce-157	1	27	28	28	NUM
globalce-157	1	28	,	,	PUNCT
globalce-157	1	29	2023	2023	NUM
globalce-157	1	30	an	an	DET
globalce-157	1	31	analysis	analysis	NOUN
globalce-157	1	32	of	of	ADP
globalce-157	1	33	adverse	adverse	ADJ
globalce-157	1	34	event	event	NOUN
globalce-157	1	35	reports	report	NOUN
globalce-157	1	36	in	in	ADP
globalce-157	1	37	fda	fda	PROPN
globalce-157	1	38	’s	’s	PART
globalce-157	1	39	maude	maude	PROPN
globalce-157	1	40	database	database	NOUN
globalce-157	1	41	by	by	ADP
globalce-157	1	42	spilios	spilio	NOUN
globalce-157	1	43	zisimopoulos	zisimopoulo	NOUN
globalce-157	1	44	,	,	PUNCT
globalce-157	1	45	nicolas	nicolas	PROPN
globalce-157	1	46	pallikarakis	pallikarakis	PROPN
globalce-157	1	47	institute	institute	PROPN
globalce-157	1	48	of	of	ADP
globalce-157	1	49	biomedical	biomedical	ADJ
globalce-157	1	50	technology	technology	NOUN
globalce-157	1	51	(	(	PUNCT
globalce-157	1	52	inbit	inbit	NOUN
globalce-157	1	53	)	)	PUNCT
globalce-157	1	54	,	,	PUNCT
globalce-157	1	55	greece	greece	PROPN
globalce-157	1	56	abstract	abstract	ADJ
globalce-157	1	57	background	background	NOUN
globalce-157	1	58	and	and	CCONJ
globalce-157	1	59	objectives	objective	NOUN
globalce-157	1	60	:	:	PUNCT
globalce-157	1	61	medical	medical	ADJ
globalce-157	1	62	devices	device	NOUN
globalce-157	1	63	(	(	PUNCT
globalce-157	1	64	mds	mds	PROPN
globalce-157	1	65	)	)	PUNCT
globalce-157	1	66	are	be	AUX
globalce-157	1	67	pivotal	pivotal	ADJ
globalce-157	1	68	in	in	ADP
globalce-157	1	69	the	the	DET
globalce-157	1	70	modern	modern	ADJ
globalce-157	1	71	healthcare	healthcare	PROPN
globalce-157	1	72	environment	environment	NOUN
globalce-157	1	73	.	.	PUNCT
globalce-157	2	1	adverse	adverse	ADJ
globalce-157	2	2	events	event	NOUN
globalce-157	2	3	are	be	AUX
globalce-157	2	4	an	an	DET
globalce-157	2	5	expected	expected	ADJ
globalce-157	2	6	part	part	NOUN
globalce-157	2	7	of	of	ADP
globalce-157	2	8	an	an	DET
globalce-157	2	9	md	md	PROPN
globalce-157	2	10	’s	’s	PART
globalce-157	2	11	lifecycle	lifecycle	NOUN
globalce-157	2	12	.	.	PUNCT
globalce-157	3	1	various	various	ADJ
globalce-157	3	2	vigilance	vigilance	NOUN
globalce-157	3	3	systems	system	NOUN
globalce-157	3	4	have	have	AUX
globalce-157	3	5	been	be	AUX
globalce-157	3	6	established	establish	VERB
globalce-157	3	7	worldwide	worldwide	ADV
globalce-157	3	8	to	to	PART
globalce-157	3	9	prevent	prevent	VERB
globalce-157	3	10	such	such	ADJ
globalce-157	3	11	events	event	NOUN
globalce-157	3	12	'	'	PART
globalce-157	3	13	recurrence	recurrence	NOUN
globalce-157	3	14	.	.	PUNCT
globalce-157	4	1	the	the	DET
globalce-157	4	2	manufacturer	manufacturer	NOUN
globalce-157	4	3	and	and	CCONJ
globalce-157	4	4	user	user	NOUN
globalce-157	4	5	facility	facility	NOUN
globalce-157	4	6	device	device	NOUN
globalce-157	4	7	experience	experience	NOUN
globalce-157	4	8	(	(	PUNCT
globalce-157	4	9	maude	maude	NOUN
globalce-157	4	10	)	)	PUNCT
globalce-157	4	11	database	database	NOUN
globalce-157	4	12	of	of	ADP
globalce-157	4	13	the	the	DET
globalce-157	4	14	us	us	PROPN
globalce-157	4	15	food	food	NOUN
globalce-157	4	16	and	and	CCONJ
globalce-157	4	17	drug	drug	PROPN
globalce-157	4	18	administration	administration	PROPN
globalce-157	4	19	(	(	PUNCT
globalce-157	4	20	fda	fda	PROPN
globalce-157	4	21	)	)	PUNCT
globalce-157	4	22	is	be	AUX
globalce-157	4	23	a	a	DET
globalce-157	4	24	publicly	publicly	ADV
globalce-157	4	25	accessible	accessible	ADJ
globalce-157	4	26	database	database	NOUN
globalce-157	4	27	that	that	PRON
globalce-157	4	28	contains	contain	VERB
globalce-157	4	29	data	datum	NOUN
globalce-157	4	30	on	on	ADP
globalce-157	4	31	medical	medical	ADJ
globalce-157	4	32	device	device	NOUN
globalce-157	4	33	reports	report	NOUN
globalce-157	4	34	(	(	PUNCT
globalce-157	4	35	mdrs	mdr	NOUN
globalce-157	4	36	)	)	PUNCT
globalce-157	4	37	submitted	submit	VERB
globalce-157	4	38	to	to	ADP
globalce-157	4	39	fda	fda	PROPN
globalce-157	4	40	since	since	SCONJ
globalce-157	4	41	1991	1991	NUM
globalce-157	4	42	.	.	PUNCT
globalce-157	5	1	this	this	DET
globalce-157	5	2	study	study	NOUN
globalce-157	5	3	aims	aim	VERB
globalce-157	5	4	to	to	PART
globalce-157	5	5	examine	examine	VERB
globalce-157	5	6	the	the	DET
globalce-157	5	7	evolution	evolution	NOUN
globalce-157	5	8	of	of	ADP
globalce-157	5	9	md	md	PROPN
globalce-157	5	10	adverse	adverse	ADJ
globalce-157	5	11	event	event	NOUN
globalce-157	5	12	reports	report	VERB
globalce-157	5	13	and	and	CCONJ
globalce-157	5	14	analyze	analyze	VERB
globalce-157	5	15	several	several	ADJ
globalce-157	5	16	characteristic	characteristic	ADJ
globalce-157	5	17	parameters	parameter	NOUN
globalce-157	5	18	as	as	SCONJ
globalce-157	5	19	they	they	PRON
globalce-157	5	20	evolved	evolve	VERB
globalce-157	5	21	during	during	ADP
globalce-157	5	22	the	the	DET
globalce-157	5	23	last	last	ADJ
globalce-157	5	24	three	three	NUM
globalce-157	5	25	decades	decade	NOUN
globalce-157	5	26	.	.	PUNCT
globalce-157	6	1	material	material	NOUN
globalce-157	6	2	and	and	CCONJ
globalce-157	6	3	methods	method	NOUN
globalce-157	6	4	:	:	PUNCT
globalce-157	6	5	an	an	DET
globalce-157	6	6	analysis	analysis	NOUN
globalce-157	6	7	of	of	ADP
globalce-157	6	8	maude	maude	NOUN
globalce-157	6	9	data	datum	NOUN
globalce-157	6	10	was	be	AUX
globalce-157	6	11	performed	perform	VERB
globalce-157	6	12	to	to	PART
globalce-157	6	13	examine	examine	VERB
globalce-157	6	14	the	the	DET
globalce-157	6	15	outcomes	outcome	NOUN
globalce-157	6	16	and	and	CCONJ
globalce-157	6	17	device	device	NOUN
globalce-157	6	18	characteristics	characteristic	NOUN
globalce-157	6	19	of	of	ADP
globalce-157	6	20	adverse	adverse	ADJ
globalce-157	6	21	event	event	NOUN
globalce-157	6	22	reports	report	VERB
globalce-157	6	23	from	from	ADP
globalce-157	6	24	1991	1991	NUM
globalce-157	6	25	up	up	ADP
globalce-157	6	26	to	to	ADP
globalce-157	6	27	11/2022	11/2022	NUM
globalce-157	6	28	.	.	PUNCT
globalce-157	7	1	these	these	DET
globalce-157	7	2	outcomes	outcome	NOUN
globalce-157	7	3	included	include	VERB
globalce-157	7	4	the	the	DET
globalce-157	7	5	event	event	NOUN
globalce-157	7	6	type	type	NOUN
globalce-157	7	7	,	,	PUNCT
globalce-157	7	8	remedial	remedial	ADJ
globalce-157	7	9	action	action	NOUN
globalce-157	7	10	,	,	PUNCT
globalce-157	7	11	report	report	NOUN
globalce-157	7	12	source	source	NOUN
globalce-157	7	13	,	,	PUNCT
globalce-157	7	14	reporter	reporter	NOUN
globalce-157	7	15	occupation	occupation	NOUN
globalce-157	7	16	and	and	CCONJ
globalce-157	7	17	device	device	NOUN
globalce-157	7	18	evaluation	evaluation	NOUN
globalce-157	7	19	by	by	ADP
globalce-157	7	20	manufacturer	manufacturer	NOUN
globalce-157	7	21	.	.	PUNCT
globalce-157	8	1	specific	specific	ADJ
globalce-157	8	2	md	md	PROPN
globalce-157	8	3	groups	group	NOUN
globalce-157	8	4	were	be	AUX
globalce-157	8	5	analyzed	analyze	VERB
globalce-157	8	6	separately	separately	ADV
globalce-157	8	7	to	to	PART
globalce-157	8	8	examine	examine	VERB
globalce-157	8	9	their	their	PRON
globalce-157	8	10	effect	effect	NOUN
globalce-157	8	11	on	on	ADP
globalce-157	8	12	the	the	DET
globalce-157	8	13	event	event	NOUN
globalce-157	8	14	outcomes	outcome	NOUN
globalce-157	8	15	.	.	PUNCT
globalce-157	9	1	segregated	segregate	VERB
globalce-157	9	2	files	file	NOUN
globalce-157	9	3	of	of	ADP
globalce-157	9	4	the	the	DET
globalce-157	9	5	database	database	NOUN
globalce-157	9	6	that	that	PRON
globalce-157	9	7	contain	contain	VERB
globalce-157	9	8	different	different	ADJ
globalce-157	9	9	types	type	NOUN
globalce-157	9	10	of	of	ADP
globalce-157	9	11	information	information	NOUN
globalce-157	9	12	on	on	ADP
globalce-157	9	13	adverse	adverse	ADJ
globalce-157	9	14	event	event	NOUN
globalce-157	9	15	reports	report	NOUN
globalce-157	9	16	were	be	AUX
globalce-157	9	17	combined	combine	VERB
globalce-157	9	18	to	to	PART
globalce-157	9	19	investigate	investigate	VERB
globalce-157	9	20	the	the	DET
globalce-157	9	21	various	various	ADJ
globalce-157	9	22	aspects	aspect	NOUN
globalce-157	9	23	of	of	ADP
globalce-157	9	24	these	these	DET
globalce-157	9	25	reports	report	NOUN
globalce-157	9	26	.	.	PUNCT
globalce-157	10	1	results	result	NOUN
globalce-157	10	2	:	:	PUNCT
globalce-157	10	3	event	event	NOUN
globalce-157	10	4	outcomes	outcome	NOUN
globalce-157	10	5	are	be	AUX
globalce-157	10	6	presented	present	VERB
globalce-157	10	7	as	as	ADP
globalce-157	10	8	annual	annual	ADJ
globalce-157	10	9	histograms	histogram	NOUN
globalce-157	10	10	.	.	PUNCT
globalce-157	11	1	an	an	DET
globalce-157	11	2	overall	overall	NOUN
globalce-157	11	3	of	of	ADP
globalce-157	11	4	about	about	ADV
globalce-157	11	5	15	15	NUM
globalce-157	11	6	million	million	NUM
globalce-157	11	7	reports	report	NOUN
globalce-157	11	8	have	have	AUX
globalce-157	11	9	been	be	AUX
globalce-157	11	10	submitted	submit	VERB
globalce-157	11	11	to	to	ADP
globalce-157	11	12	maude	maude	NOUN
globalce-157	11	13	during	during	ADP
globalce-157	11	14	the	the	DET
globalce-157	11	15	30	30	NUM
globalce-157	11	16	years	year	NOUN
globalce-157	11	17	examined	examine	VERB
globalce-157	11	18	with	with	ADP
globalce-157	11	19	more	more	ADJ
globalce-157	11	20	than	than	ADP
globalce-157	11	21	2.5	2.5	NUM
globalce-157	11	22	million	million	NUM
globalce-157	11	23	of	of	ADP
globalce-157	11	24	them	they	PRON
globalce-157	11	25	during	during	ADP
globalce-157	11	26	the	the	DET
globalce-157	11	27	first	first	ADJ
globalce-157	11	28	10	10	NUM
globalce-157	11	29	months	month	NOUN
globalce-157	11	30	of	of	ADP
globalce-157	11	31	2022	2022	NUM
globalce-157	11	32	.	.	PUNCT
globalce-157	12	1	this	this	DET
globalce-157	12	2	number	number	NOUN
globalce-157	12	3	is	be	AUX
globalce-157	12	4	growing	grow	VERB
globalce-157	12	5	at	at	ADP
globalce-157	12	6	an	an	DET
globalce-157	12	7	increasing	increase	VERB
globalce-157	12	8	rate	rate	NOUN
globalce-157	12	9	.	.	PUNCT
globalce-157	13	1	most	most	ADJ
globalce-157	13	2	of	of	ADP
globalce-157	13	3	the	the	DET
globalce-157	13	4	events	event	NOUN
globalce-157	13	5	(	(	PUNCT
globalce-157	13	6	63.5	63.5	NUM
globalce-157	13	7	%	%	NOUN
globalce-157	13	8	)	)	PUNCT
globalce-157	13	9	have	have	AUX
globalce-157	13	10	resulted	result	VERB
globalce-157	13	11	in	in	ADP
globalce-157	13	12	simple	simple	ADJ
globalce-157	13	13	device	device	NOUN
globalce-157	13	14	malfunctions	malfunction	NOUN
globalce-157	13	15	without	without	ADP
globalce-157	13	16	serious	serious	ADJ
globalce-157	13	17	implications	implication	NOUN
globalce-157	13	18	to	to	ADP
globalce-157	13	19	the	the	DET
globalce-157	13	20	patient	patient	NOUN
globalce-157	13	21	.	.	PUNCT
globalce-157	14	1	depending	depend	VERB
globalce-157	14	2	on	on	ADP
globalce-157	14	3	the	the	DET
globalce-157	14	4	device	device	NOUN
globalce-157	14	5	type	type	NOUN
globalce-157	14	6	,	,	PUNCT
globalce-157	14	7	however	however	ADV
globalce-157	14	8	,	,	PUNCT
globalce-157	14	9	the	the	DET
globalce-157	14	10	health	health	NOUN
globalce-157	14	11	risks	risk	NOUN
globalce-157	14	12	may	may	AUX
globalce-157	14	13	be	be	AUX
globalce-157	14	14	higher	high	ADJ
globalce-157	14	15	(	(	PUNCT
globalce-157	14	16	98.4	98.4	NUM
globalce-157	14	17	%	%	NOUN
globalce-157	14	18	injuries	injury	NOUN
globalce-157	14	19	from	from	ADP
globalce-157	14	20	specific	specific	ADJ
globalce-157	14	21	dental	dental	ADJ
globalce-157	14	22	implants	implant	NOUN
globalce-157	14	23	and	and	CCONJ
globalce-157	14	24	3.2	3.2	NUM
globalce-157	14	25	%	%	NOUN
globalce-157	14	26	deaths	death	NOUN
globalce-157	14	27	from	from	ADP
globalce-157	14	28	implantable	implantable	ADJ
globalce-157	14	29	defibrillators	defibrillator	NOUN
globalce-157	14	30	)	)	PUNCT
globalce-157	14	31	.	.	PUNCT
globalce-157	15	1	about	about	ADV
globalce-157	15	2	20	20	NUM
globalce-157	15	3	%	%	NOUN
globalce-157	15	4	of	of	ADP
globalce-157	15	5	the	the	DET
globalce-157	15	6	reports	report	NOUN
globalce-157	15	7	have	have	AUX
globalce-157	15	8	led	lead	VERB
globalce-157	15	9	to	to	PART
globalce-157	15	10	recalls	recall	NOUN
globalce-157	15	11	or	or	CCONJ
globalce-157	15	12	corrective	corrective	ADJ
globalce-157	15	13	actions	action	NOUN
globalce-157	15	14	.	.	PUNCT
globalce-157	16	1	most	most	ADJ
globalce-157	16	2	of	of	ADP
globalce-157	16	3	the	the	DET
globalce-157	16	4	reports	report	NOUN
globalce-157	16	5	(	(	PUNCT
globalce-157	16	6	96	96	NUM
globalce-157	16	7	%	%	NOUN
globalce-157	16	8	)	)	PUNCT
globalce-157	16	9	are	be	AUX
globalce-157	16	10	submitted	submit	VERB
globalce-157	16	11	by	by	ADP
globalce-157	16	12	manufacturers	manufacturer	NOUN
globalce-157	16	13	,	,	PUNCT
globalce-157	16	14	and	and	CCONJ
globalce-157	16	15	over	over	ADP
globalce-157	16	16	70	70	NUM
globalce-157	16	17	%	%	NOUN
globalce-157	16	18	of	of	ADP
globalce-157	16	19	the	the	DET
globalce-157	16	20	devices	device	NOUN
globalce-157	16	21	returned	return	VERB
globalce-157	16	22	to	to	ADP
globalce-157	16	23	them	they	PRON
globalce-157	16	24	are	be	AUX
globalce-157	16	25	evaluated	evaluate	VERB
globalce-157	16	26	,	,	PUNCT
globalce-157	16	27	following	follow	VERB
globalce-157	16	28	the	the	DET
globalce-157	16	29	requirements	requirement	NOUN
globalce-157	16	30	of	of	ADP
globalce-157	16	31	fda	fda	PROPN
globalce-157	16	32	21	21	NUM
globalce-157	16	33	cfr	cfr	PROPN
globalce-157	16	34	,	,	PUNCT
globalce-157	16	35	803	803	NUM
globalce-157	16	36	.	.	PUNCT
globalce-157	17	1	finally	finally	ADV
globalce-157	17	2	,	,	PUNCT
globalce-157	17	3	the	the	DET
globalce-157	17	4	average	average	ADJ
globalce-157	17	5	device	device	NOUN
globalce-157	17	6	age	age	NOUN
globalce-157	17	7	was	be	AUX
globalce-157	17	8	found	find	VERB
globalce-157	17	9	to	to	PART
globalce-157	17	10	be	be	AUX
globalce-157	17	11	5.4	5.4	NUM
globalce-157	17	12	years	year	NOUN
globalce-157	17	13	,	,	PUNCT
globalce-157	17	14	with	with	ADP
globalce-157	17	15	an	an	DET
globalce-157	17	16	increasing	increase	VERB
globalce-157	17	17	tendency	tendency	NOUN
globalce-157	17	18	observed	observe	VERB
globalce-157	17	19	over	over	ADP
globalce-157	17	20	the	the	DET
globalce-157	17	21	years	year	NOUN
globalce-157	17	22	,	,	PUNCT
globalce-157	17	23	while	while	SCONJ
globalce-157	17	24	43	43	NUM
globalce-157	17	25	%	%	NOUN
globalce-157	17	26	of	of	ADP
globalce-157	17	27	the	the	DET
globalce-157	17	28	events	event	NOUN
globalce-157	17	29	that	that	PRON
globalce-157	17	30	occur	occur	VERB
globalce-157	17	31	are	be	AUX
globalce-157	17	32	associated	associate	VERB
globalce-157	17	33	with	with	ADP
globalce-157	17	34	devices	device	NOUN
globalce-157	17	35	during	during	ADP
globalce-157	17	36	their	their	PRON
globalce-157	17	37	first	first	ADJ
globalce-157	17	38	year	year	NOUN
globalce-157	17	39	of	of	ADP
globalce-157	17	40	operation	operation	NOUN
globalce-157	17	41	.	.	PUNCT
globalce-157	18	1	conclusion	conclusion	NOUN
globalce-157	18	2	:	:	PUNCT
globalce-157	18	3	a	a	DET
globalce-157	18	4	medical	medical	ADJ
globalce-157	18	5	device	device	NOUN
globalce-157	18	6	adverse	adverse	ADJ
globalce-157	18	7	event	event	NOUN
globalce-157	18	8	reporting	reporting	NOUN
globalce-157	18	9	system	system	NOUN
globalce-157	18	10	is	be	AUX
globalce-157	18	11	a	a	DET
globalce-157	18	12	critical	critical	ADJ
globalce-157	18	13	component	component	NOUN
globalce-157	18	14	of	of	ADP
globalce-157	18	15	safety	safety	NOUN
globalce-157	18	16	in	in	ADP
globalce-157	18	17	the	the	DET
globalce-157	18	18	use	use	NOUN
globalce-157	18	19	of	of	ADP
globalce-157	18	20	medical	medical	ADJ
globalce-157	18	21	technology	technology	NOUN
globalce-157	18	22	in	in	ADP
globalce-157	18	23	modern	modern	ADJ
globalce-157	18	24	healthcare	healthcare	NOUN
globalce-157	18	25	.	.	PUNCT
globalce-157	19	1	the	the	DET
globalce-157	19	2	information	information	NOUN
globalce-157	19	3	available	available	ADJ
globalce-157	19	4	in	in	ADP
globalce-157	19	5	maude	maude	PROPN
globalce-157	19	6	and	and	CCONJ
globalce-157	19	7	its	its	PRON
globalce-157	19	8	use	use	NOUN
globalce-157	19	9	continues	continue	VERB
globalce-157	19	10	to	to	PART
globalce-157	19	11	grow	grow	VERB
globalce-157	19	12	at	at	ADP
globalce-157	19	13	an	an	DET
globalce-157	19	14	accelerated	accelerated	ADJ
globalce-157	19	15	rate	rate	NOUN
globalce-157	19	16	and	and	CCONJ
globalce-157	19	17	allows	allow	VERB
globalce-157	19	18	critical	critical	ADJ
globalce-157	19	19	improvements	improvement	NOUN
globalce-157	19	20	of	of	ADP
globalce-157	19	21	mds	mds	PROPN
globalce-157	19	22	,	,	PUNCT
globalce-157	19	23	especially	especially	ADV
globalce-157	19	24	in	in	ADP
globalce-157	19	25	terms	term	NOUN
globalce-157	19	26	of	of	ADP
globalce-157	19	27	risk	risk	NOUN
globalce-157	19	28	prevention	prevention	NOUN
globalce-157	19	29	,	,	PUNCT
globalce-157	19	30	as	as	SCONJ
globalce-157	19	31	it	it	PRON
globalce-157	19	32	gives	give	VERB
globalce-157	19	33	perception	perception	NOUN
globalce-157	19	34	about	about	ADP
globalce-157	19	35	their	their	PRON
globalce-157	19	36	safety	safety	NOUN
globalce-157	19	37	issues	issue	NOUN
globalce-157	19	38	.	.	PUNCT
globalce-157	20	1	fda	fda	PROPN
globalce-157	20	2	has	have	AUX
globalce-157	20	3	taken	take	VERB
globalce-157	20	4	various	various	ADJ
globalce-157	20	5	steps	step	NOUN
globalce-157	20	6	to	to	PART
globalce-157	20	7	encourage	encourage	VERB
globalce-157	20	8	and	and	CCONJ
globalce-157	20	9	facilitate	facilitate	VERB
globalce-157	20	10	adverse	adverse	ADJ
globalce-157	20	11	event	event	NOUN
globalce-157	20	12	reporting	report	VERB
globalce-157	20	13	and	and	CCONJ
globalce-157	20	14	make	make	VERB
globalce-157	20	15	the	the	DET
globalce-157	20	16	data	datum	NOUN
globalce-157	20	17	available	available	ADJ
globalce-157	20	18	to	to	ADP
globalce-157	20	19	the	the	DET
globalce-157	20	20	public	public	NOUN
globalce-157	20	21	.	.	PUNCT
globalce-157	21	1	keywords	keyword	NOUN
globalce-157	21	2	–	–	PUNCT
globalce-157	21	3	maude	maude	PROPN
globalce-157	21	4	,	,	PUNCT
globalce-157	21	5	fda	fda	PROPN
globalce-157	21	6	,	,	PUNCT
globalce-157	21	7	adverse	adverse	ADJ
globalce-157	21	8	events	event	NOUN
globalce-157	21	9	reports	report	NOUN
globalce-157	21	10	,	,	PUNCT
globalce-157	21	11	medical	medical	ADJ
globalce-157	21	12	devices	device	NOUN
globalce-157	21	13	,	,	PUNCT
globalce-157	21	14	vigilance	vigilance	NOUN
globalce-157	21	15	.	.	PUNCT
globalce-157	22	1	copyright	copyright	NOUN
globalce-157	22	2	©	©	PROPN
globalce-157	22	3	2023	2023	NUM
globalce-157	22	4	.	.	PUNCT
globalce-157	23	1	this	this	PRON
globalce-157	23	2	is	be	AUX
globalce-157	23	3	an	an	DET
globalce-157	23	4	open	open	ADJ
globalce-157	23	5	-	-	PUNCT
globalce-157	23	6	access	access	NOUN
globalce-157	23	7	article	article	NOUN
globalce-157	23	8	distributed	distribute	VERB
globalce-157	23	9	under	under	ADP
globalce-157	23	10	the	the	DET
globalce-157	23	11	terms	term	NOUN
globalce-157	23	12	of	of	ADP
globalce-157	23	13	the	the	DET
globalce-157	23	14	creative	creative	ADJ
globalce-157	23	15	commons	common	NOUN
globalce-157	23	16	attribution	attribution	NOUN
globalce-157	23	17	license	license	NOUN
globalce-157	23	18	(	(	PUNCT
globalce-157	23	19	cc	cc	NOUN
globalce-157	23	20	by	by	ADV
globalce-157	23	21	):	):	PUNCT
globalce-157	23	22	creative	creative	ADJ
globalce-157	23	23	commons	common	NOUN
globalce-157	23	24	attribution	attribution	NOUN
globalce-157	23	25	4.0	4.0	NUM
globalce-157	23	26	international	international	NOUN
globalce-157	23	27	cc	cc	NOUN
globalce-157	23	28	by	by	ADP
globalce-157	23	29	4.0	4.0	NUM
globalce-157	23	30	.	.	PUNCT
globalce-157	24	1	the	the	DET
globalce-157	24	2	use	use	NOUN
globalce-157	24	3	,	,	PUNCT
globalce-157	24	4	distribution	distribution	NOUN
globalce-157	24	5	or	or	CCONJ
globalce-157	24	6	reproduction	reproduction	NOUN
globalce-157	24	7	in	in	ADP
globalce-157	24	8	other	other	ADJ
globalce-157	24	9	forums	forum	NOUN
globalce-157	24	10	is	be	AUX
globalce-157	24	11	permitted	permit	VERB
globalce-157	24	12	,	,	PUNCT
globalce-157	24	13	provided	provide	VERB
globalce-157	24	14	the	the	DET
globalce-157	24	15	original	original	ADJ
globalce-157	24	16	author(s	author(s	NOUN
globalce-157	24	17	)	)	PUNCT
globalce-157	24	18	and	and	CCONJ
globalce-157	24	19	the	the	DET
globalce-157	24	20	copyright	copyright	NOUN
globalce-157	24	21	owner(s	owner(s	NOUN
globalce-157	24	22	)	)	PUNCT
globalce-157	24	23	are	be	AUX
globalce-157	24	24	credited	credit	VERB
globalce-157	24	25	and	and	CCONJ
globalce-157	24	26	that	that	SCONJ
globalce-157	24	27	the	the	DET
globalce-157	24	28	original	original	ADJ
globalce-157	24	29	publication	publication	NOUN
globalce-157	24	30	in	in	ADP
globalce-157	24	31	this	this	DET
globalce-157	24	32	journal	journal	NOUN
globalce-157	24	33	is	be	AUX
globalce-157	24	34	cited	cite	VERB
globalce-157	24	35	,	,	PUNCT
globalce-157	24	36	in	in	ADP
globalce-157	24	37	accordance	accordance	NOUN
globalce-157	24	38	with	with	ADP
globalce-157	24	39	accepted	accept	VERB
globalce-157	24	40	academic	academic	ADJ
globalce-157	24	41	practice	practice	NOUN
globalce-157	24	42	.	.	PUNCT
globalce-157	25	1	no	no	DET
globalce-157	25	2	use	use	NOUN
globalce-157	25	3	,	,	PUNCT
globalce-157	25	4	distribution	distribution	NOUN
globalce-157	25	5	or	or	CCONJ
globalce-157	25	6	reproduction	reproduction	NOUN
globalce-157	25	7	is	be	AUX
globalce-157	25	8	permitted	permit	VERB
globalce-157	25	9	which	which	PRON
globalce-157	25	10	does	do	AUX
globalce-157	25	11	not	not	PART
globalce-157	25	12	comply	comply	VERB
globalce-157	25	13	with	with	ADP
globalce-157	25	14	these	these	DET
globalce-157	25	15	terms	term	NOUN
globalce-157	25	16	.	.	PUNCT
globalce-157	25	17	http://www.globalce.org	http://www.globalce.org	PUNCT
globalce-157	26	1	http://globalce.org	http://globalce.org	PROPN
globalce-157	26	2	http://globalce.org	http://globalce.org	PROPN
globalce-157	26	3	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-157	26	4	https://creativecommons.org/licenses/by/4.0/	https://creativecommons.org/licenses/by/4.0/	PROPN
globalce-157	26	5	zisimopoulos	zisimopoulos	PROPN
globalce-157	26	6	,	,	PUNCT
globalce-157	26	7	pallikarakis	pallikarakis	PROPN
globalce-157	26	8	:	:	PUNCT
globalce-157	26	9	an	an	DET
globalce-157	26	10	analysis	analysis	NOUN
globalce-157	26	11	of	of	ADP
globalce-157	26	12	adverse	adverse	ADJ
globalce-157	26	13	event	event	NOUN
globalce-157	26	14	reports	report	NOUN
globalce-157	26	15	in	in	ADP
globalce-157	26	16	fda	fda	PROPN
globalce-157	26	17	’s	’s	PART
globalce-157	26	18	maude	maude	PROPN
globalce-157	26	19	database	database	PROPN
globalce-157	26	20	j	j	PROPN
globalce-157	26	21	global	global	ADJ
globalce-157	26	22	clinical	clinical	ADJ
globalce-157	26	23	engineering	engineering	PROPN
globalce-157	26	24	vol.6	vol.6	PROPN
globalce-157	26	25	issue	issue	NOUN
globalce-157	26	26	1	1	NUM
globalce-157	26	27	:	:	SYM
globalce-157	26	28	2023	2023	NUM
globalce-157	26	29	6	6	NUM
globalce-157	26	30	introduction	introduction	NOUN
globalce-157	26	31	in	in	ADP
globalce-157	26	32	today	today	NOUN
globalce-157	26	33	's	's	PART
globalce-157	26	34	world	world	NOUN
globalce-157	26	35	,	,	PUNCT
globalce-157	26	36	medical	medical	ADJ
globalce-157	26	37	devices	device	NOUN
globalce-157	26	38	(	(	PUNCT
globalce-157	26	39	mds	mds	PROPN
globalce-157	26	40	)	)	PUNCT
globalce-157	26	41	have	have	AUX
globalce-157	26	42	become	become	VERB
globalce-157	26	43	a	a	DET
globalce-157	26	44	fundamental	fundamental	ADJ
globalce-157	26	45	component	component	NOUN
globalce-157	26	46	of	of	ADP
globalce-157	26	47	modern	modern	ADJ
globalce-157	26	48	healthcare	healthcare	NOUN
globalce-157	26	49	systems	system	NOUN
globalce-157	26	50	.	.	PUNCT
globalce-157	27	1	mds	mds	PROPN
globalce-157	27	2	range	range	NOUN
globalce-157	27	3	from	from	ADP
globalce-157	27	4	simple	simple	ADJ
globalce-157	27	5	face	face	NOUN
globalce-157	27	6	masks	mask	NOUN
globalce-157	27	7	and	and	CCONJ
globalce-157	27	8	syringes	syrinx	NOUN
globalce-157	27	9	to	to	ADP
globalce-157	27	10	complex	complex	ADJ
globalce-157	27	11	implantable	implantable	ADJ
globalce-157	27	12	devices	device	NOUN
globalce-157	27	13	and	and	CCONJ
globalce-157	27	14	medical	medical	ADJ
globalce-157	27	15	imaging	imaging	NOUN
globalce-157	27	16	systems	system	NOUN
globalce-157	27	17	and	and	CCONJ
globalce-157	27	18	are	be	AUX
globalce-157	27	19	used	use	VERB
globalce-157	27	20	to	to	PART
globalce-157	27	21	diagnose	diagnose	VERB
globalce-157	27	22	,	,	PUNCT
globalce-157	27	23	treat	treat	NOUN
globalce-157	27	24	,	,	PUNCT
globalce-157	27	25	and	and	CCONJ
globalce-157	27	26	manage	manage	VERB
globalce-157	27	27	various	various	ADJ
globalce-157	27	28	medical	medical	ADJ
globalce-157	27	29	conditions	condition	NOUN
globalce-157	27	30	.	.	PUNCT
globalce-157	28	1	however	however	ADV
globalce-157	28	2	,	,	PUNCT
globalce-157	28	3	like	like	ADP
globalce-157	28	4	any	any	DET
globalce-157	28	5	other	other	ADJ
globalce-157	28	6	medical	medical	ADJ
globalce-157	28	7	procedure	procedure	NOUN
globalce-157	28	8	,	,	PUNCT
globalce-157	28	9	mds	mds	PROPN
globalce-157	28	10	are	be	AUX
globalce-157	28	11	not	not	PART
globalce-157	28	12	without	without	ADP
globalce-157	28	13	risks	risk	NOUN
globalce-157	28	14	.	.	PUNCT
globalce-157	29	1	adverse	adverse	ADJ
globalce-157	29	2	events	event	NOUN
globalce-157	29	3	can	can	AUX
globalce-157	29	4	occur	occur	VERB
globalce-157	29	5	due	due	ADP
globalce-157	29	6	to	to	ADP
globalce-157	29	7	various	various	ADJ
globalce-157	29	8	factors	factor	NOUN
globalce-157	29	9	like	like	ADP
globalce-157	29	10	device	device	NOUN
globalce-157	29	11	malfunction	malfunction	NOUN
globalce-157	29	12	or	or	CCONJ
globalce-157	29	13	misuse	misuse	NOUN
globalce-157	29	14	,	,	PUNCT
globalce-157	29	15	resulting	result	VERB
globalce-157	29	16	in	in	ADP
globalce-157	29	17	serious	serious	ADJ
globalce-157	29	18	patient	patient	ADJ
globalce-157	29	19	harm	harm	NOUN
globalce-157	29	20	.	.	PUNCT
globalce-157	30	1	to	to	PART
globalce-157	30	2	prevent	prevent	VERB
globalce-157	30	3	and	and	CCONJ
globalce-157	30	4	mitigate	mitigate	VERB
globalce-157	30	5	these	these	DET
globalce-157	30	6	risks	risk	NOUN
globalce-157	30	7	,	,	PUNCT
globalce-157	30	8	it	it	PRON
globalce-157	30	9	is	be	AUX
globalce-157	30	10	essential	essential	ADJ
globalce-157	30	11	to	to	PART
globalce-157	30	12	have	have	VERB
globalce-157	30	13	a	a	DET
globalce-157	30	14	robust	robust	ADJ
globalce-157	30	15	md	md	PROPN
globalce-157	30	16	vigilance	vigilance	NOUN
globalce-157	30	17	system	system	NOUN
globalce-157	30	18	involving	involve	VERB
globalce-157	30	19	health	health	NOUN
globalce-157	30	20	competent	competent	ADJ
globalce-157	30	21	authorities1	authorities1	NOUN
globalce-157	30	22	and	and	CCONJ
globalce-157	30	23	md	md	PROPN
globalce-157	30	24	manufacturers	manufacturer	NOUN
globalce-157	30	25	that	that	PRON
globalce-157	30	26	investigate	investigate	VERB
globalce-157	30	27	and	and	CCONJ
globalce-157	30	28	eventually	eventually	ADV
globalce-157	30	29	perform	perform	VERB
globalce-157	30	30	necessary	necessary	ADJ
globalce-157	30	31	remedial	remedial	ADJ
globalce-157	30	32	actions	action	NOUN
globalce-157	30	33	following	follow	VERB
globalce-157	30	34	adverse	adverse	ADJ
globalce-157	30	35	events	event	NOUN
globalce-157	30	36	with	with	ADP
globalce-157	30	37	mds	mds	PROPN
globalce-157	30	38	.	.	PUNCT
globalce-157	31	1	in	in	ADP
globalce-157	31	2	most	most	ADV
globalce-157	31	3	developed	develop	VERB
globalce-157	31	4	countries	country	NOUN
globalce-157	31	5	md	md	PROPN
globalce-157	31	6	vigilance	vigilance	PROPN
globalce-157	31	7	systems	system	NOUN
globalce-157	31	8	have	have	AUX
globalce-157	31	9	been	be	AUX
globalce-157	31	10	implemented	implement	VERB
globalce-157	31	11	for	for	ADP
globalce-157	31	12	more	more	ADJ
globalce-157	31	13	than	than	ADP
globalce-157	31	14	30	30	NUM
globalce-157	31	15	years	year	NOUN
globalce-157	31	16	,	,	PUNCT
globalce-157	31	17	aiming	aim	VERB
globalce-157	31	18	to	to	PART
globalce-157	31	19	reduce	reduce	VERB
globalce-157	31	20	the	the	DET
globalce-157	31	21	likelihood	likelihood	NOUN
globalce-157	31	22	of	of	ADP
globalce-157	31	23	similar	similar	ADJ
globalce-157	31	24	adverse	adverse	ADJ
globalce-157	31	25	events	event	NOUN
globalce-157	31	26	happening	happen	VERB
globalce-157	31	27	again	again	ADV
globalce-157	31	28	in	in	ADP
globalce-157	31	29	another	another	DET
globalce-157	31	30	place	place	NOUN
globalce-157	31	31	and	and	CCONJ
globalce-157	31	32	time	time	NOUN
globalce-157	31	33	.	.	PUNCT
globalce-157	32	1	the	the	DET
globalce-157	32	2	cornerstone	cornerstone	NOUN
globalce-157	32	3	of	of	ADP
globalce-157	32	4	the	the	DET
globalce-157	32	5	md	md	PROPN
globalce-157	32	6	vigilance	vigilance	PROPN
globalce-157	32	7	systems	system	NOUN
globalce-157	32	8	is	be	AUX
globalce-157	32	9	adverse	adverse	ADJ
globalce-157	32	10	event	event	NOUN
globalce-157	32	11	reporting	report	VERB
globalce-157	32	12	.	.	PUNCT
globalce-157	33	1	a	a	DET
globalce-157	33	2	medical	medical	ADJ
globalce-157	33	3	device	device	NOUN
globalce-157	33	4	adverse	adverse	ADJ
globalce-157	33	5	event	event	NOUN
globalce-157	33	6	reporting	reporting	NOUN
globalce-157	33	7	system	system	NOUN
globalce-157	33	8	is	be	AUX
globalce-157	33	9	a	a	DET
globalce-157	33	10	mechanism	mechanism	NOUN
globalce-157	33	11	that	that	PRON
globalce-157	33	12	enables	enable	VERB
globalce-157	33	13	healthcare	healthcare	NOUN
globalce-157	33	14	facilities	facility	NOUN
globalce-157	33	15	,	,	PUNCT
globalce-157	33	16	patients	patient	NOUN
globalce-157	33	17	,	,	PUNCT
globalce-157	33	18	and	and	CCONJ
globalce-157	33	19	manufacturers	manufacturer	NOUN
globalce-157	33	20	to	to	PART
globalce-157	33	21	report	report	VERB
globalce-157	33	22	incidents	incident	NOUN
globalce-157	33	23	associated	associate	VERB
globalce-157	33	24	with	with	ADP
globalce-157	33	25	mds	mds	PROPN
globalce-157	33	26	.	.	PUNCT
globalce-157	34	1	these	these	DET
globalce-157	34	2	systems	system	NOUN
globalce-157	34	3	provide	provide	VERB
globalce-157	34	4	standardized	standardized	ADJ
globalce-157	34	5	processes	process	NOUN
globalce-157	34	6	for	for	ADP
globalce-157	34	7	reporting	report	VERB
globalce-157	34	8	such	such	ADJ
globalce-157	34	9	events	event	NOUN
globalce-157	34	10	and	and	CCONJ
globalce-157	34	11	allow	allow	VERB
globalce-157	34	12	the	the	DET
globalce-157	34	13	collecting	collecting	NOUN
globalce-157	34	14	and	and	CCONJ
globalce-157	34	15	analysis	analysis	NOUN
globalce-157	34	16	of	of	ADP
globalce-157	34	17	information	information	NOUN
globalce-157	34	18	related	relate	VERB
globalce-157	34	19	to	to	ADP
globalce-157	34	20	md	md	PROPN
globalce-157	34	21	safety	safety	NOUN
globalce-157	34	22	.	.	PUNCT
globalce-157	35	1	such	such	DET
globalce-157	35	2	a	a	DET
globalce-157	35	3	system	system	NOUN
globalce-157	35	4	is	be	AUX
globalce-157	35	5	of	of	ADP
globalce-157	35	6	the	the	DET
globalce-157	35	7	utmost	utmost	ADJ
globalce-157	35	8	importance	importance	NOUN
globalce-157	35	9	,	,	PUNCT
globalce-157	35	10	as	as	SCONJ
globalce-157	35	11	it	it	PRON
globalce-157	35	12	is	be	AUX
globalce-157	35	13	critical	critical	ADJ
globalce-157	35	14	in	in	ADP
globalce-157	35	15	ensuring	ensure	VERB
globalce-157	35	16	patient	patient	ADJ
globalce-157	35	17	safety	safety	NOUN
globalce-157	35	18	and	and	CCONJ
globalce-157	35	19	improving	improve	VERB
globalce-157	35	20	healthcare	healthcare	NOUN
globalce-157	35	21	quality	quality	NOUN
globalce-157	35	22	.	.	PUNCT
globalce-157	36	1	one	one	NUM
globalce-157	36	2	of	of	ADP
globalce-157	36	3	the	the	DET
globalce-157	36	4	primary	primary	ADJ
globalce-157	36	5	benefits	benefit	NOUN
globalce-157	36	6	of	of	ADP
globalce-157	36	7	an	an	DET
globalce-157	36	8	md	md	PROPN
globalce-157	36	9	adverse	adverse	ADJ
globalce-157	36	10	event	event	NOUN
globalce-157	36	11	reporting	reporting	NOUN
globalce-157	36	12	system	system	NOUN
globalce-157	36	13	is	be	AUX
globalce-157	36	14	that	that	SCONJ
globalce-157	36	15	it	it	PRON
globalce-157	36	16	enables	enable	VERB
globalce-157	36	17	healthcare	healthcare	NOUN
globalce-157	36	18	providers	provider	NOUN
globalce-157	36	19	and	and	CCONJ
globalce-157	36	20	manufacturers	manufacturer	NOUN
globalce-157	36	21	to	to	PART
globalce-157	36	22	identify	identify	VERB
globalce-157	36	23	and	and	CCONJ
globalce-157	36	24	address	address	VERB
globalce-157	36	25	safety	safety	NOUN
globalce-157	36	26	concerns	concern	NOUN
globalce-157	36	27	related	relate	VERB
globalce-157	36	28	to	to	ADP
globalce-157	36	29	medical	medical	ADJ
globalce-157	36	30	devices	device	NOUN
globalce-157	36	31	.	.	PUNCT
globalce-157	37	1	the	the	DET
globalce-157	37	2	report	report	NOUN
globalce-157	37	3	of	of	ADP
globalce-157	37	4	adverse	adverse	ADJ
globalce-157	37	5	events	event	NOUN
globalce-157	37	6	by	by	ADP
globalce-157	37	7	healthcare	healthcare	NOUN
globalce-157	37	8	facilities	facility	NOUN
globalce-157	37	9	helps	help	VERB
globalce-157	37	10	manufacturers	manufacturer	NOUN
globalce-157	37	11	gain	gain	VERB
globalce-157	37	12	insight	insight	NOUN
globalce-157	37	13	into	into	ADP
globalce-157	37	14	the	the	DET
globalce-157	37	15	performance	performance	NOUN
globalce-157	37	16	and	and	CCONJ
globalce-157	37	17	safety	safety	NOUN
globalce-157	37	18	of	of	ADP
globalce-157	37	19	their	their	PRON
globalce-157	37	20	devices	device	NOUN
globalce-157	37	21	.	.	PUNCT
globalce-157	38	1	the	the	DET
globalce-157	38	2	information	information	NOUN
globalce-157	38	3	provided	provide	VERB
globalce-157	38	4	can	can	AUX
globalce-157	38	5	then	then	ADV
globalce-157	38	6	be	be	AUX
globalce-157	38	7	used	use	VERB
globalce-157	38	8	to	to	PART
globalce-157	38	9	identify	identify	VERB
globalce-157	38	10	design	design	NOUN
globalce-157	38	11	flaws	flaw	NOUN
globalce-157	38	12	,	,	PUNCT
globalce-157	38	13	manufacturing	manufacturing	NOUN
globalce-157	38	14	defects	defect	NOUN
globalce-157	38	15	,	,	PUNCT
globalce-157	38	16	software	software	NOUN
globalce-157	38	17	problems	problem	NOUN
globalce-157	38	18	,	,	PUNCT
globalce-157	38	19	or	or	CCONJ
globalce-157	38	20	other	other	ADJ
globalce-157	38	21	issues	issue	NOUN
globalce-157	38	22	that	that	PRON
globalce-157	38	23	may	may	AUX
globalce-157	38	24	contribute	contribute	VERB
globalce-157	38	25	to	to	ADP
globalce-157	38	26	adverse	adverse	ADJ
globalce-157	38	27	events	event	NOUN
globalce-157	38	28	and	and	CCONJ
globalce-157	38	29	take	take	VERB
globalce-157	38	30	appropriate	appropriate	ADJ
globalce-157	38	31	action	action	NOUN
globalce-157	38	32	to	to	PART
globalce-157	38	33	address	address	VERB
globalce-157	38	34	these	these	DET
globalce-157	38	35	issues	issue	NOUN
globalce-157	38	36	,	,	PUNCT
globalce-157	38	37	such	such	ADJ
globalce-157	38	38	as	as	ADP
globalce-157	38	39	modifying	modify	VERB
globalce-157	38	40	the	the	DET
globalce-157	38	41	device	device	NOUN
globalce-157	38	42	design	design	NOUN
globalce-157	38	43	or	or	CCONJ
globalce-157	38	44	implementing	implement	VERB
globalce-157	38	45	new	new	ADJ
globalce-157	38	46	quality	quality	NOUN
globalce-157	38	47	control	control	NOUN
globalce-157	38	48	processes	process	NOUN
globalce-157	38	49	.	.	PUNCT
globalce-157	39	1	on	on	ADP
globalce-157	39	2	the	the	DET
globalce-157	39	3	other	other	ADJ
globalce-157	39	4	hand	hand	NOUN
globalce-157	39	5	,	,	PUNCT
globalce-157	39	6	when	when	SCONJ
globalce-157	39	7	information	information	NOUN
globalce-157	39	8	about	about	ADP
globalce-157	39	9	the	the	DET
globalce-157	39	10	risks	risk	NOUN
globalce-157	39	11	associated	associate	VERB
globalce-157	39	12	with	with	ADP
globalce-157	39	13	specific	specific	ADJ
globalce-157	39	14	devices	device	NOUN
globalce-157	39	15	is	be	AUX
globalce-157	39	16	publically	publically	ADV
globalce-157	39	17	available	available	ADJ
globalce-157	39	18	,	,	PUNCT
globalce-157	39	19	healthcare	healthcare	NOUN
globalce-157	39	20	providers	provider	NOUN
globalce-157	39	21	can	can	AUX
globalce-157	39	22	investigate	investigate	VERB
globalce-157	39	23	whether	whether	SCONJ
globalce-157	39	24	an	an	DET
globalce-157	39	25	event	event	NOUN
globalce-157	39	26	they	they	PRON
globalce-157	39	27	faced	face	VERB
globalce-157	39	28	has	have	AUX
globalce-157	39	29	also	also	ADV
globalce-157	39	30	been	be	AUX
globalce-157	39	31	manifested	manifest	VERB
globalce-157	39	32	in	in	ADP
globalce-157	39	33	a	a	DET
globalce-157	39	34	different	different	ADJ
globalce-157	39	35	facility	facility	NOUN
globalce-157	39	36	,	,	PUNCT
globalce-157	39	37	and	and	CCONJ
globalce-157	39	38	,	,	PUNCT
globalce-157	39	39	in	in	ADP
globalce-157	39	40	that	that	DET
globalce-157	39	41	case	case	NOUN
globalce-157	39	42	,	,	PUNCT
globalce-157	39	43	follow	follow	VERB
globalce-157	39	44	the	the	DET
globalce-157	39	45	instructions	instruction	NOUN
globalce-157	39	46	that	that	PRON
globalce-157	39	47	the	the	DET
globalce-157	39	48	manufacturer	manufacturer	NOUN
globalce-157	39	49	has	have	AUX
globalce-157	39	50	proposed	propose	VERB
globalce-157	39	51	.	.	PUNCT
globalce-157	40	1	a	a	DET
globalce-157	40	2	medical	medical	ADJ
globalce-157	40	3	device	device	NOUN
globalce-157	40	4	adverse	adverse	ADJ
globalce-157	40	5	event	event	NOUN
globalce-157	40	6	reporting	report	VERB
globalce-157	40	7	system	system	NOUN
globalce-157	40	8	also	also	ADV
globalce-157	40	9	enables	enable	VERB
globalce-157	40	10	better	well	ADJ
globalce-157	40	11	communication	communication	NOUN
globalce-157	40	12	between	between	ADP
globalce-157	40	13	healthcare	healthcare	NOUN
globalce-157	40	14	providers	provider	NOUN
globalce-157	40	15	,	,	PUNCT
globalce-157	40	16	regulatory	regulatory	ADJ
globalce-157	40	17	agencies	agency	NOUN
globalce-157	40	18	,	,	PUNCT
globalce-157	40	19	and	and	CCONJ
globalce-157	40	20	competent	competent	ADJ
globalce-157	40	21	authorities	authority	NOUN
globalce-157	40	22	.	.	PUNCT
globalce-157	41	1	when	when	SCONJ
globalce-157	41	2	adverse	adverse	ADJ
globalce-157	41	3	events	event	NOUN
globalce-157	41	4	are	be	AUX
globalce-157	41	5	reported	report	VERB
globalce-157	41	6	,	,	PUNCT
globalce-157	41	7	the	the	DET
globalce-157	41	8	authorities	authority	NOUN
globalce-157	41	9	can	can	AUX
globalce-157	41	10	use	use	VERB
globalce-157	41	11	this	this	DET
globalce-157	41	12	information	information	NOUN
globalce-157	41	13	to	to	PART
globalce-157	41	14	take	take	VERB
globalce-157	41	15	appropriate	appropriate	ADJ
globalce-157	41	16	action	action	NOUN
globalce-157	41	17	when	when	SCONJ
globalce-157	41	18	necessary	necessary	ADJ
globalce-157	41	19	.	.	PUNCT
globalce-157	42	1	for	for	ADP
globalce-157	42	2	example	example	NOUN
globalce-157	42	3	,	,	PUNCT
globalce-157	42	4	if	if	SCONJ
globalce-157	42	5	a	a	DET
globalce-157	42	6	particular	particular	ADJ
globalce-157	42	7	device	device	NOUN
globalce-157	42	8	is	be	AUX
globalce-157	42	9	associated	associate	VERB
globalce-157	42	10	with	with	ADP
globalce-157	42	11	a	a	DET
globalce-157	42	12	high	high	ADJ
globalce-157	42	13	rate	rate	NOUN
globalce-157	42	14	of	of	ADP
globalce-157	42	15	adverse	adverse	ADJ
globalce-157	42	16	events	event	NOUN
globalce-157	42	17	,	,	PUNCT
globalce-157	42	18	regulatory	regulatory	ADJ
globalce-157	42	19	agencies	agency	NOUN
globalce-157	42	20	may	may	AUX
globalce-157	42	21	require	require	VERB
globalce-157	42	22	additional	additional	ADJ
globalce-157	42	23	testing	testing	NOUN
globalce-157	42	24	or	or	CCONJ
globalce-157	42	25	labeling	labeling	NOUN
globalce-157	42	26	changes	change	NOUN
globalce-157	42	27	from	from	ADP
globalce-157	42	28	the	the	DET
globalce-157	42	29	manufacturer	manufacturer	NOUN
globalce-157	42	30	to	to	PART
globalce-157	42	31	improve	improve	VERB
globalce-157	42	32	safety	safety	NOUN
globalce-157	42	33	.	.	PUNCT
globalce-157	43	1	finally	finally	ADV
globalce-157	43	2	,	,	PUNCT
globalce-157	43	3	a	a	DET
globalce-157	43	4	medical	medical	ADJ
globalce-157	43	5	device	device	NOUN
globalce-157	43	6	adverse	adverse	ADJ
globalce-157	43	7	event	event	NOUN
globalce-157	43	8	reporting	reporting	NOUN
globalce-157	43	9	system	system	NOUN
globalce-157	43	10	can	can	AUX
globalce-157	43	11	promote	promote	VERB
globalce-157	43	12	transparency	transparency	NOUN
globalce-157	43	13	and	and	CCONJ
globalce-157	43	14	accountability	accountability	NOUN
globalce-157	43	15	in	in	ADP
globalce-157	43	16	the	the	DET
globalce-157	43	17	healthcare	healthcare	NOUN
globalce-157	43	18	industry.(a	industry.(a	NOUN
globalce-157	43	19	)	)	PUNCT
globalce-157	43	20	by	by	ADP
globalce-157	43	21	publicly	publicly	ADV
globalce-157	43	22	making	make	VERB
globalce-157	43	23	information	information	NOUN
globalce-157	43	24	about	about	ADP
globalce-157	43	25	adverse	adverse	ADJ
globalce-157	43	26	events	event	NOUN
globalce-157	43	27	,	,	PUNCT
globalce-157	43	28	the	the	DET
globalce-157	43	29	system	system	NOUN
globalce-157	43	30	can	can	AUX
globalce-157	43	31	help	help	VERB
globalce-157	43	32	hold	hold	VERB
globalce-157	43	33	manufacturers	manufacturer	NOUN
globalce-157	43	34	,	,	PUNCT
globalce-157	43	35	distributors	distributor	NOUN
globalce-157	43	36	,	,	PUNCT
globalce-157	43	37	and	and	CCONJ
globalce-157	43	38	healthcare	healthcare	NOUN
globalce-157	43	39	providers	provider	NOUN
globalce-157	43	40	accountable	accountable	ADJ
globalce-157	43	41	for	for	ADP
globalce-157	43	42	their	their	PRON
globalce-157	43	43	actions	action	NOUN
globalce-157	43	44	.	.	PUNCT
globalce-157	44	1	this	this	PRON
globalce-157	44	2	can	can	AUX
globalce-157	44	3	help	help	VERB
globalce-157	44	4	with	with	ADP
globalce-157	44	5	the	the	DET
globalce-157	44	6	trust	trust	NOUN
globalce-157	44	7	-	-	PUNCT
globalce-157	44	8	building	building	NOUN
globalce-157	44	9	process	process	NOUN
globalce-157	44	10	between	between	ADP
globalce-157	44	11	patients	patient	NOUN
globalce-157	44	12	and	and	CCONJ
globalce-157	44	13	healthcare	healthcare	NOUN
globalce-157	44	14	providers	provider	NOUN
globalce-157	44	15	and	and	CCONJ
globalce-157	44	16	ensure	ensure	VERB
globalce-157	44	17	that	that	SCONJ
globalce-157	44	18	the	the	DET
globalce-157	44	19	healthcare	healthcare	NOUN
globalce-157	44	20	industry	industry	NOUN
globalce-157	44	21	is	be	AUX
globalce-157	44	22	held	hold	VERB
globalce-157	44	23	to	to	ADP
globalce-157	44	24	the	the	DET
globalce-157	44	25	highest	high	ADJ
globalce-157	44	26	safety	safety	NOUN
globalce-157	44	27	and	and	CCONJ
globalce-157	44	28	quality	quality	NOUN
globalce-157	44	29	standards	standard	NOUN
globalce-157	44	30	.	.	PUNCT
globalce-157	45	1	the	the	DET
globalce-157	45	2	aim	aim	NOUN
globalce-157	45	3	of	of	ADP
globalce-157	45	4	this	this	DET
globalce-157	45	5	study	study	NOUN
globalce-157	45	6	is	be	AUX
globalce-157	45	7	to	to	PART
globalce-157	45	8	examine	examine	VERB
globalce-157	45	9	the	the	DET
globalce-157	45	10	evolution	evolution	NOUN
globalce-157	45	11	of	of	ADP
globalce-157	45	12	medical	medical	ADJ
globalce-157	45	13	device	device	NOUN
globalce-157	45	14	adverse	adverse	ADJ
globalce-157	45	15	event	event	NOUN
globalce-157	45	16	reports	report	NOUN
globalce-157	45	17	,	,	PUNCT
globalce-157	45	18	available	available	ADJ
globalce-157	45	19	at	at	ADP
globalce-157	45	20	the	the	DET
globalce-157	45	21	manufacturer	manufacturer	NOUN
globalce-157	45	22	and	and	CCONJ
globalce-157	45	23	user	user	NOUN
globalce-157	45	24	facility	facility	NOUN
globalce-157	45	25	device	device	NOUN
globalce-157	45	26	experience	experience	NOUN
globalce-157	45	27	(	(	PUNCT
globalce-157	45	28	maude	maude	NOUN
globalce-157	45	29	)	)	PUNCT
globalce-157	45	30	database	database	NOUN
globalce-157	45	31	of	of	ADP
globalce-157	45	32	the	the	DET
globalce-157	45	33	us	us	PROPN
globalce-157	45	34	food	food	NOUN
globalce-157	45	35	and	and	CCONJ
globalce-157	45	36	drug	drug	PROPN
globalce-157	45	37	administration	administration	PROPN
globalce-157	45	38	(	(	PUNCT
globalce-157	45	39	fda	fda	PROPN
globalce-157	45	40	)	)	PUNCT
globalce-157	45	41	and	and	CCONJ
globalce-157	45	42	analyze	analyze	VERB
globalce-157	45	43	several	several	ADJ
globalce-157	45	44	characteristic	characteristic	ADJ
globalce-157	45	45	parameters	parameter	NOUN
globalce-157	45	46	of	of	ADP
globalce-157	45	47	these	these	DET
globalce-157	45	48	reports	report	NOUN
globalce-157	45	49	as	as	SCONJ
globalce-157	45	50	they	they	PRON
globalce-157	45	51	evolved	evolve	VERB
globalce-157	45	52	during	during	ADP
globalce-157	45	53	the	the	DET
globalce-157	45	54	last	last	ADJ
globalce-157	45	55	three	three	NUM
globalce-157	45	56	decades	decade	NOUN
globalce-157	45	57	.	.	PUNCT
globalce-157	46	1	adverse	adverse	ADJ
globalce-157	46	2	events	event	NOUN
globalce-157	46	3	reporting	report	VERB
globalce-157	46	4	systems	system	NOUN
globalce-157	46	5	there	there	PRON
globalce-157	46	6	are	be	VERB
globalce-157	46	7	several	several	ADJ
globalce-157	46	8	mds	mds	PROPN
globalce-157	46	9	adverse	adverse	ADJ
globalce-157	46	10	event	event	NOUN
globalce-157	46	11	reporting	report	VERB
globalce-157	46	12	systems	system	NOUN
globalce-157	46	13	worldwide	worldwide	ADV
globalce-157	46	14	,	,	PUNCT
globalce-157	46	15	aiming	aim	VERB
globalce-157	46	16	to	to	PART
globalce-157	46	17	address	address	VERB
globalce-157	46	18	safety	safety	NOUN
globalce-157	46	19	issues	issue	NOUN
globalce-157	46	20	that	that	PRON
globalce-157	46	21	arise	arise	VERB
globalce-157	46	22	from	from	ADP
globalce-157	46	23	the	the	DET
globalce-157	46	24	use	use	NOUN
globalce-157	46	25	of	of	ADP
globalce-157	46	26	medical	medical	ADJ
globalce-157	46	27	devices	device	NOUN
globalce-157	46	28	.	.	PUNCT
globalce-157	47	1	the	the	DET
globalce-157	47	2	reports	report	NOUN
globalce-157	47	3	can	can	AUX
globalce-157	47	4	be	be	AUX
globalce-157	47	5	generally	generally	ADV
globalce-157	47	6	made	make	VERB
globalce-157	47	7	by	by	ADP
globalce-157	47	8	manufacturers	manufacturer	NOUN
globalce-157	47	9	,	,	PUNCT
globalce-157	47	10	healthcare	healthcare	NOUN
globalce-157	47	11	professionals	professional	NOUN
globalce-157	47	12	and	and	CCONJ
globalce-157	47	13	volunteers	volunteer	NOUN
globalce-157	47	14	.	.	PUNCT
globalce-157	48	1	fda	fda	PROPN
globalce-157	48	2	's	's	PART
globalce-157	48	3	maude	maude	PROPN
globalce-157	48	4	database	database	NOUN
globalce-157	48	5	,	,	PUNCT
globalce-157	48	6	designed	design	VERB
globalce-157	48	7	to	to	PART
globalce-157	48	8	collect	collect	VERB
globalce-157	48	9	reports	report	NOUN
globalce-157	48	10	of	of	ADP
globalce-157	48	11	adverse	adverse	ADJ
globalce-157	48	12	events	event	NOUN
globalce-157	48	13	associated	associate	VERB
globalce-157	48	14	with	with	ADP
globalce-157	48	15	mds	mds	PROPN
globalce-157	48	16	is	be	AUX
globalce-157	48	17	the	the	DET
globalce-157	48	18	most	most	ADV
globalce-157	48	19	well	well	ADV
globalce-157	48	20	known	know	VERB
globalce-157	48	21	,	,	PUNCT
globalce-157	48	22	it	it	PRON
globalce-157	48	23	is	be	AUX
globalce-157	48	24	available	available	ADJ
globalce-157	48	25	to	to	ADP
globalce-157	48	26	the	the	DET
globalce-157	48	27	public	public	NOUN
globalce-157	48	28	and	and	CCONJ
globalce-157	48	29	can	can	AUX
globalce-157	48	30	be	be	AUX
globalce-157	48	31	accessed	access	VERB
globalce-157	48	32	online	online	ADV
globalce-157	48	33	,	,	PUNCT
globalce-157	48	34	allowing	allow	VERB
globalce-157	48	35	the	the	DET
globalce-157	48	36	analysis	analysis	NOUN
globalce-157	48	37	of	of	ADP
globalce-157	48	38	the	the	DET
globalce-157	48	39	available	available	ADJ
globalce-157	48	40	data.2	data.2	PROPN
globalce-157	48	41	maude	maude	NOUN
globalce-157	48	42	contains	contain	VERB
globalce-157	48	43	the	the	DET
globalce-157	48	44	reports	report	NOUN
globalce-157	48	45	submitted	submit	VERB
globalce-157	48	46	through	through	ADP
globalce-157	48	47	the	the	DET
globalce-157	48	48	medical	medical	ADJ
globalce-157	48	49	device	device	NOUN
globalce-157	48	50	reporting	report	VERB
globalce-157	48	51	(	(	PUNCT
globalce-157	48	52	mdr	mdr	NOUN
globalce-157	48	53	)	)	PUNCT
globalce-157	48	54	system	system	NOUN
globalce-157	48	55	,	,	PUNCT
globalce-157	48	56	which	which	PRON
globalce-157	48	57	are	be	AUX
globalce-157	48	58	used	use	VERB
globalce-157	48	59	by	by	ADP
globalce-157	48	60	manufacturers	manufacturer	NOUN
globalce-157	48	61	,	,	PUNCT
globalce-157	48	62	a	a	DET
globalce-157	48	63	the	the	DET
globalce-157	48	64	competent	competent	ADJ
globalce-157	48	65	authorities	authority	NOUN
globalce-157	48	66	for	for	ADP
globalce-157	48	67	medical	medical	ADJ
globalce-157	48	68	devices	device	NOUN
globalce-157	48	69	(	(	PUNCT
globalce-157	48	70	camd	camd	NOUN
globalce-157	48	71	)	)	PUNCT
globalce-157	48	72	facilitate	facilitate	NOUN
globalce-157	48	73	implementing	implement	VERB
globalce-157	48	74	and	and	CCONJ
globalce-157	48	75	enforcing	enforce	VERB
globalce-157	48	76	the	the	DET
globalce-157	48	77	regulations	regulation	NOUN
globalce-157	48	78	on	on	ADP
globalce-157	48	79	medical	medical	ADJ
globalce-157	48	80	devices	device	NOUN
globalce-157	48	81	and	and	CCONJ
globalce-157	48	82	on	on	ADV
globalce-157	48	83	in	in	ADP
globalce-157	48	84	vitro	vitro	X
globalce-157	48	85	diagnostic	diagnostic	ADJ
globalce-157	48	86	medical	medical	ADJ
globalce-157	48	87	devices	device	NOUN
globalce-157	48	88	in	in	ADP
globalce-157	48	89	the	the	DET
globalce-157	48	90	eu	eu	PROPN
globalce-157	48	91	.	.	PROPN
globalce-157	48	92	https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd	https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd	PROPN
globalce-157	48	93	https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd	https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd	PROPN
globalce-157	48	94	7	7	NUM
globalce-157	48	95	j	j	PROPN
globalce-157	48	96	global	global	ADJ
globalce-157	48	97	clinical	clinical	ADJ
globalce-157	48	98	engineering	engineering	PROPN
globalce-157	48	99	vol.6	vol.6	PROPN
globalce-157	48	100	issue	issue	NOUN
globalce-157	48	101	1	1	NUM
globalce-157	48	102	:	:	SYM
globalce-157	48	103	2023	2023	NUM
globalce-157	48	104	zisimopoulos	zisimopoulo	NOUN
globalce-157	48	105	,	,	PUNCT
globalce-157	48	106	pallikarakis	pallikarakis	PROPN
globalce-157	48	107	:	:	PUNCT
globalce-157	48	108	an	an	DET
globalce-157	48	109	analysis	analysis	NOUN
globalce-157	48	110	of	of	ADP
globalce-157	48	111	adverse	adverse	ADJ
globalce-157	48	112	event	event	NOUN
globalce-157	48	113	reports	report	NOUN
globalce-157	48	114	in	in	ADP
globalce-157	48	115	fda	fda	PROPN
globalce-157	48	116	’s	’s	PART
globalce-157	48	117	maude	maude	PROPN
globalce-157	48	118	database	database	PROPN
globalce-157	48	119	importers	importer	NOUN
globalce-157	48	120	and	and	CCONJ
globalce-157	48	121	users	user	NOUN
globalce-157	48	122	of	of	ADP
globalce-157	48	123	mds	mds	PROPN
globalce-157	48	124	.	.	PUNCT
globalce-157	49	1	the	the	DET
globalce-157	49	2	mdr	mdr	PROPN
globalce-157	49	3	system	system	NOUN
globalce-157	49	4	is	be	AUX
globalce-157	49	5	a	a	DET
globalce-157	49	6	mandatory	mandatory	ADJ
globalce-157	49	7	reporting	reporting	NOUN
globalce-157	49	8	system	system	NOUN
globalce-157	49	9	,	,	PUNCT
globalce-157	49	10	and	and	CCONJ
globalce-157	49	11	manufacturers	manufacturer	NOUN
globalce-157	49	12	must	must	AUX
globalce-157	49	13	report	report	VERB
globalce-157	49	14	any	any	DET
globalce-157	49	15	adverse	adverse	ADJ
globalce-157	49	16	event	event	NOUN
globalce-157	49	17	that	that	PRON
globalce-157	49	18	involves	involve	VERB
globalce-157	49	19	their	their	PRON
globalce-157	49	20	device.3	device.3	PROPN
globalce-157	49	21	the	the	DET
globalce-157	49	22	european	european	PROPN
globalce-157	49	23	databank	databank	PROPN
globalce-157	49	24	on	on	ADP
globalce-157	49	25	medical	medical	ADJ
globalce-157	49	26	devices	device	NOUN
globalce-157	49	27	(	(	PUNCT
globalce-157	49	28	eudamed	eudame	VERB
globalce-157	49	29	)	)	PUNCT
globalce-157	49	30	is	be	AUX
globalce-157	49	31	maintained	maintain	VERB
globalce-157	49	32	by	by	ADP
globalce-157	49	33	the	the	DET
globalce-157	49	34	european	european	PROPN
globalce-157	49	35	union	union	PROPN
globalce-157	49	36	(	(	PUNCT
globalce-157	49	37	eu	eu	PROPN
globalce-157	49	38	)	)	PUNCT
globalce-157	49	39	and	and	CCONJ
globalce-157	49	40	is	be	AUX
globalce-157	49	41	designed	design	VERB
globalce-157	49	42	to	to	PART
globalce-157	49	43	provide	provide	VERB
globalce-157	49	44	a	a	DET
globalce-157	49	45	living	live	VERB
globalce-157	49	46	picture	picture	NOUN
globalce-157	49	47	of	of	ADP
globalce-157	49	48	the	the	DET
globalce-157	49	49	lifecycle	lifecycle	NOUN
globalce-157	49	50	of	of	ADP
globalce-157	49	51	mds	mds	PROPN
globalce-157	49	52	,	,	PUNCT
globalce-157	49	53	including	include	VERB
globalce-157	49	54	modules	module	NOUN
globalce-157	49	55	related	relate	VERB
globalce-157	49	56	to	to	ADP
globalce-157	49	57	device	device	NOUN
globalce-157	49	58	registration	registration	NOUN
globalce-157	49	59	,	,	PUNCT
globalce-157	49	60	notified	notify	VERB
globalce-157	49	61	bodied	bodied	ADJ
globalce-157	49	62	and	and	CCONJ
globalce-157	49	63	certificates	certificate	NOUN
globalce-157	49	64	among	among	ADP
globalce-157	49	65	others	other	NOUN
globalce-157	49	66	.	.	PUNCT
globalce-157	50	1	the	the	DET
globalce-157	50	2	database	database	NOUN
globalce-157	50	3	has	have	AUX
globalce-157	50	4	been	be	AUX
globalce-157	50	5	established	establish	VERB
globalce-157	50	6	in	in	ADP
globalce-157	50	7	the	the	DET
globalce-157	50	8	2000s	2000s	NUM
globalce-157	50	9	according	accord	VERB
globalce-157	50	10	to	to	ADP
globalce-157	50	11	the	the	DET
globalce-157	50	12	mds	mds	NOUN
globalce-157	50	13	directives	directive	NOUN
globalce-157	50	14	:	:	PUNCT
globalce-157	50	15	90/385	90/385	NUM
globalce-157	50	16	/	/	SYM
globalce-157	50	17	eec	eec	PROPN
globalce-157	50	18	for	for	ADP
globalce-157	50	19	the	the	DET
globalce-157	50	20	active	active	ADJ
globalce-157	50	21	implantable	implantable	ADJ
globalce-157	50	22	medical	medical	ADJ
globalce-157	50	23	devices	device	NOUN
globalce-157	50	24	(	(	PUNCT
globalce-157	50	25	aimd	aimd	NOUN
globalce-157	50	26	)	)	PUNCT
globalce-157	50	27	,	,	PUNCT
globalce-157	50	28	93/42	93/42	NUM
globalce-157	50	29	/	/	SYM
globalce-157	50	30	eec	eec	PROPN
globalce-157	50	31	(	(	PUNCT
globalce-157	50	32	md	md	PROPN
globalce-157	50	33	)	)	PUNCT
globalce-157	50	34	for	for	ADP
globalce-157	50	35	the	the	DET
globalce-157	50	36	medical	medical	ADJ
globalce-157	50	37	devices	device	NOUN
globalce-157	50	38	and	and	CCONJ
globalce-157	50	39	98/79	98/79	NUM
globalce-157	50	40	/	/	SYM
globalce-157	50	41	ec	ec	PROPN
globalce-157	50	42	for	for	ADP
globalce-157	50	43	the	the	DET
globalce-157	50	44	in	in	X
globalce-157	50	45	vitro	vitro	X
globalce-157	50	46	diagnostics	diagnostic	NOUN
globalce-157	50	47	.	.	PUNCT
globalce-157	51	1	the	the	DET
globalce-157	51	2	eu	eu	PROPN
globalce-157	51	3	vigilance	vigilance	NOUN
globalce-157	51	4	system	system	NOUN
globalce-157	51	5	is	be	AUX
globalce-157	51	6	based	base	VERB
globalce-157	51	7	on	on	ADP
globalce-157	51	8	the	the	DET
globalce-157	51	9	meddev	meddev	NOUN
globalce-157	51	10	2.12/1	2.12/1	PROPN
globalce-157	51	11	rev.8	rev.8	NOUN
globalce-157	51	12	series	series	NOUN
globalce-157	51	13	of	of	ADP
globalce-157	51	14	guidelines	guideline	NOUN
globalce-157	51	15	of	of	ADP
globalce-157	51	16	2012(b	2012(b	NOUN
globalce-157	51	17	)	)	PUNCT
globalce-157	51	18	on	on	ADP
globalce-157	51	19	post	post	ADJ
globalce-157	51	20	-	-	ADJ
globalce-157	51	21	market	market	ADJ
globalce-157	51	22	surveillance	surveillance	NOUN
globalce-157	51	23	and	and	CCONJ
globalce-157	51	24	vigilance	vigilance	NOUN
globalce-157	51	25	system	system	NOUN
globalce-157	51	26	adopted	adopt	VERB
globalce-157	51	27	in	in	ADP
globalce-157	51	28	2019.(c	2019.(c	NUM
globalce-157	51	29	)	)	PUNCT
globalce-157	51	30	the	the	DET
globalce-157	51	31	eu	eu	PROPN
globalce-157	51	32	's	's	PART
globalce-157	51	33	new	new	ADJ
globalce-157	51	34	2017/745	2017/745	NUM
globalce-157	51	35	and	and	CCONJ
globalce-157	51	36	2017/746	2017/746	NUM
globalce-157	51	37	mdrs	mdr	NOUN
globalce-157	51	38	,	,	PUNCT
globalce-157	51	39	reshaped	reshape	VERB
globalce-157	51	40	the	the	DET
globalce-157	51	41	structure	structure	NOUN
globalce-157	51	42	and	and	CCONJ
globalce-157	51	43	use	use	NOUN
globalce-157	51	44	of	of	ADP
globalce-157	51	45	eudamed	eudame	VERB
globalce-157	51	46	to	to	PART
globalce-157	51	47	improve	improve	VERB
globalce-157	51	48	the	the	DET
globalce-157	51	49	safety	safety	NOUN
globalce-157	51	50	and	and	CCONJ
globalce-157	51	51	performance	performance	NOUN
globalce-157	51	52	requirements	requirement	NOUN
globalce-157	51	53	of	of	ADP
globalce-157	51	54	medical	medical	ADJ
globalce-157	51	55	devices	device	NOUN
globalce-157	51	56	bearing	bear	VERB
globalce-157	51	57	a	a	DET
globalce-157	51	58	ce	ce	NOUN
globalce-157	51	59	mark.4	mark.4	NOUN
globalce-157	51	60	however	however	ADV
globalce-157	51	61	,	,	PUNCT
globalce-157	51	62	access	access	NOUN
globalce-157	51	63	to	to	ADP
globalce-157	51	64	eudamed	eudamed	ADJ
globalce-157	51	65	is	be	AUX
globalce-157	51	66	restricted	restrict	VERB
globalce-157	51	67	only	only	ADV
globalce-157	51	68	to	to	ADP
globalce-157	51	69	competent	competent	ADJ
globalce-157	51	70	authorities	authority	NOUN
globalce-157	51	71	and	and	CCONJ
globalce-157	51	72	partially	partially	ADV
globalce-157	51	73	to	to	PART
globalce-157	51	74	notified	notify	VERB
globalce-157	51	75	bodies	body	NOUN
globalce-157	51	76	for	for	ADP
globalce-157	51	77	devices	device	NOUN
globalce-157	51	78	that	that	PRON
globalce-157	51	79	are	be	AUX
globalce-157	51	80	involved	involve	VERB
globalce-157	51	81	,	,	PUNCT
globalce-157	51	82	and	and	CCONJ
globalce-157	51	83	the	the	DET
globalce-157	51	84	information	information	NOUN
globalce-157	51	85	on	on	ADP
globalce-157	51	86	mds	mds	PROPN
globalce-157	51	87	related	relate	VERB
globalce-157	51	88	incident	incident	NOUN
globalce-157	51	89	reports	report	NOUN
globalce-157	51	90	is	be	AUX
globalce-157	51	91	not	not	PART
globalce-157	51	92	yet	yet	ADV
globalce-157	51	93	available	available	ADJ
globalce-157	51	94	to	to	ADP
globalce-157	51	95	other	other	ADJ
globalce-157	51	96	parties	party	NOUN
globalce-157	51	97	,	,	PUNCT
globalce-157	51	98	despite	despite	SCONJ
globalce-157	51	99	the	the	DET
globalce-157	51	100	explicit	explicit	ADJ
globalce-157	51	101	reference	reference	NOUN
globalce-157	51	102	in	in	ADP
globalce-157	51	103	the	the	DET
globalce-157	51	104	regulations	regulation	NOUN
globalce-157	51	105	.	.	PUNCT
globalce-157	52	1	various	various	ADJ
globalce-157	52	2	other	other	ADJ
globalce-157	52	3	adverse	adverse	ADJ
globalce-157	52	4	event	event	NOUN
globalce-157	52	5	reporting	reporting	NOUN
globalce-157	52	6	systems	system	NOUN
globalce-157	52	7	are	be	AUX
globalce-157	52	8	being	be	AUX
globalce-157	52	9	used	use	VERB
globalce-157	52	10	at	at	ADP
globalce-157	52	11	the	the	DET
globalce-157	52	12	national	national	ADJ
globalce-157	52	13	level	level	NOUN
globalce-157	52	14	.	.	PUNCT
globalce-157	53	1	some	some	DET
globalce-157	53	2	well	well	ADV
globalce-157	53	3	known	know	VERB
globalce-157	53	4	examples	example	NOUN
globalce-157	53	5	are	be	AUX
globalce-157	53	6	the	the	DET
globalce-157	53	7	australian	australian	ADJ
globalce-157	53	8	therapeutic	therapeutic	ADJ
globalce-157	53	9	goods	good	NOUN
globalce-157	53	10	administration	administration	NOUN
globalce-157	53	11	(	(	PUNCT
globalce-157	53	12	tga	tga	PROPN
globalce-157	53	13	)	)	PUNCT
globalce-157	53	14	adverse	adverse	ADJ
globalce-157	53	15	event	event	NOUN
globalce-157	53	16	reporting	report	VERB
globalce-157	53	17	system,5	system,5	NOUN
globalce-157	53	18	health	health	PROPN
globalce-157	53	19	canada	canada	PROPN
globalce-157	53	20	's	's	PART
globalce-157	53	21	medical	medical	ADJ
globalce-157	53	22	device	device	NOUN
globalce-157	53	23	adverse	adverse	ADJ
globalce-157	53	24	event	event	NOUN
globalce-157	53	25	reporting	report	VERB
globalce-157	53	26	(	(	PUNCT
globalce-157	53	27	mdaers),6	mdaers),6	X
globalce-157	53	28	uk	uk	PROPN
globalce-157	53	29	’s	’s	PART
globalce-157	53	30	medicines	medicine	NOUN
globalce-157	53	31	and	and	CCONJ
globalce-157	53	32	healthcare	healthcare	NOUN
globalce-157	53	33	products	product	NOUN
globalce-157	53	34	regulatory	regulatory	ADJ
globalce-157	53	35	agency	agency	NOUN
globalce-157	53	36	(	(	PUNCT
globalce-157	53	37	mhra)7	mhra)7	PROPN
globalce-157	53	38	and	and	CCONJ
globalce-157	53	39	germany	germany	PROPN
globalce-157	53	40	’s	’s	PART
globalce-157	53	41	federal	federal	PROPN
globalce-157	53	42	institute	institute	NOUN
globalce-157	53	43	for	for	ADP
globalce-157	53	44	drugs	drug	NOUN
globalce-157	53	45	and	and	CCONJ
globalce-157	53	46	medical	medical	ADJ
globalce-157	53	47	devices	device	NOUN
globalce-157	53	48	(	(	PUNCT
globalce-157	53	49	bfarm).8	bfarm).8	NOUN
globalce-157	53	50	these	these	DET
globalce-157	53	51	systems	system	NOUN
globalce-157	53	52	are	be	AUX
globalce-157	53	53	used	use	VERB
globalce-157	53	54	to	to	PART
globalce-157	53	55	report	report	VERB
globalce-157	53	56	or	or	CCONJ
globalce-157	53	57	access	access	VERB
globalce-157	53	58	adverse	adverse	ADJ
globalce-157	53	59	events	event	NOUN
globalce-157	53	60	associated	associate	VERB
globalce-157	53	61	with	with	ADP
globalce-157	53	62	mds	mds	PROPN
globalce-157	53	63	and	and	CCONJ
globalce-157	53	64	are	be	AUX
globalce-157	53	65	open	open	ADJ
globalce-157	53	66	to	to	ADP
globalce-157	53	67	healthcare	healthcare	NOUN
globalce-157	53	68	professionals	professional	NOUN
globalce-157	53	69	,	,	PUNCT
globalce-157	53	70	patients	patient	NOUN
globalce-157	53	71	and	and	CCONJ
globalce-157	53	72	manufacturers	manufacturer	NOUN
globalce-157	53	73	,	,	PUNCT
globalce-157	53	74	while	while	SCONJ
globalce-157	53	75	they	they	PRON
globalce-157	53	76	can	can	AUX
globalce-157	53	77	also	also	ADV
globalce-157	53	78	be	be	AUX
globalce-157	53	79	accessed	access	VERB
globalce-157	53	80	online	online	ADV
globalce-157	53	81	.	.	PUNCT
globalce-157	54	1	many	many	ADJ
globalce-157	54	2	other	other	ADJ
globalce-157	54	3	countries	country	NOUN
globalce-157	54	4	have	have	VERB
globalce-157	54	5	also	also	ADV
globalce-157	54	6	similar	similar	ADJ
globalce-157	54	7	systems	system	NOUN
globalce-157	54	8	in	in	ADP
globalce-157	54	9	place	place	NOUN
globalce-157	54	10	,	,	PUNCT
globalce-157	54	11	and	and	CCONJ
globalce-157	54	12	many	many	ADJ
globalce-157	54	13	manufacturers	manufacturer	NOUN
globalce-157	54	14	have	have	VERB
globalce-157	54	15	their	their	PRON
globalce-157	54	16	own	own	ADJ
globalce-157	54	17	reporting	reporting	NOUN
globalce-157	54	18	systems	system	NOUN
globalce-157	54	19	for	for	ADP
globalce-157	54	20	post	post	ADJ
globalce-157	54	21	-	-	ADJ
globalce-157	54	22	market	market	ADJ
globalce-157	54	23	surveillance	surveillance	NOUN
globalce-157	54	24	purposes	purpose	NOUN
globalce-157	54	25	.	.	PUNCT
globalce-157	55	1	relevant	relevant	ADJ
globalce-157	55	2	work	work	NOUN
globalce-157	55	3	using	use	VERB
globalce-157	55	4	maude	maude	PROPN
globalce-157	55	5	a	a	DET
globalce-157	55	6	search	search	NOUN
globalce-157	55	7	was	be	AUX
globalce-157	55	8	performed	perform	VERB
globalce-157	55	9	in	in	ADP
globalce-157	55	10	the	the	DET
globalce-157	55	11	pubmed	pubmed	PROPN
globalce-157	55	12	database	database	NOUN
globalce-157	55	13	on	on	ADP
globalce-157	55	14	papers	paper	NOUN
globalce-157	55	15	published	publish	VERB
globalce-157	55	16	from	from	ADP
globalce-157	55	17	2000	2000	NUM
globalce-157	55	18	to	to	ADP
globalce-157	55	19	date	date	NOUN
globalce-157	55	20	,	,	PUNCT
globalce-157	55	21	with	with	SCONJ
globalce-157	55	22	the	the	DET
globalce-157	55	23	term	term	NOUN
globalce-157	55	24	“	"	PUNCT
globalce-157	55	25	maude	maude	NOUN
globalce-157	55	26	database	database	NOUN
globalce-157	55	27	”	"	PUNCT
globalce-157	55	28	included	include	VERB
globalce-157	55	29	in	in	ADP
globalce-157	55	30	the	the	DET
globalce-157	55	31	title	title	NOUN
globalce-157	55	32	or	or	CCONJ
globalce-157	55	33	abstract	abstract	NOUN
globalce-157	55	34	of	of	ADP
globalce-157	55	35	the	the	DET
globalce-157	55	36	paper	paper	NOUN
globalce-157	55	37	(	(	PUNCT
globalce-157	55	38	maude	maude	NOUN
globalce-157	55	39	database	database	NOUN
globalce-157	55	40	[	[	X
globalce-157	55	41	title	title	NOUN
globalce-157	55	42	/	/	SYM
globalce-157	55	43	abstract	abstract	NOUN
globalce-157	55	44	]	]	X
globalce-157	55	45	)	)	PUNCT
globalce-157	55	46	.	.	PUNCT
globalce-157	56	1	this	this	PRON
globalce-157	56	2	was	be	AUX
globalce-157	56	3	done	do	VERB
globalce-157	56	4	to	to	PART
globalce-157	56	5	include	include	VERB
globalce-157	56	6	only	only	ADJ
globalce-157	56	7	papers	paper	NOUN
globalce-157	56	8	whose	whose	DET
globalce-157	56	9	content	content	NOUN
globalce-157	56	10	was	be	AUX
globalce-157	56	11	focused	focus	VERB
globalce-157	56	12	on	on	ADP
globalce-157	56	13	the	the	DET
globalce-157	56	14	analysis	analysis	NOUN
globalce-157	56	15	of	of	ADP
globalce-157	56	16	maude	maude	PROPN
globalce-157	56	17	’s	’s	PART
globalce-157	56	18	data	data	PROPN
globalce-157	56	19	,	,	PUNCT
globalce-157	56	20	and	and	CCONJ
globalce-157	56	21	the	the	DET
globalce-157	56	22	search	search	NOUN
globalce-157	56	23	yielded	yield	VERB
globalce-157	56	24	303	303	NUM
globalce-157	56	25	results	result	NOUN
globalce-157	56	26	.	.	PUNCT
globalce-157	57	1	next	next	ADV
globalce-157	57	2	,	,	PUNCT
globalce-157	57	3	another	another	DET
globalce-157	57	4	query	query	NOUN
globalce-157	57	5	was	be	AUX
globalce-157	57	6	performed	perform	VERB
globalce-157	57	7	,	,	PUNCT
globalce-157	57	8	adding	add	VERB
globalce-157	57	9	the	the	DET
globalce-157	57	10	terms	term	NOUN
globalce-157	57	11	“	"	PUNCT
globalce-157	57	12	maude	maude	NOUN
globalce-157	57	13	”	"	PUNCT
globalce-157	57	14	and	and	CCONJ
globalce-157	57	15	“	"	PUNCT
globalce-157	57	16	fda	fda	PROPN
globalce-157	57	17	”	"	PUNCT
globalce-157	57	18	in	in	ADP
globalce-157	57	19	the	the	DET
globalce-157	57	20	title	title	NOUN
globalce-157	57	21	or	or	CCONJ
globalce-157	57	22	abstract	abstract	NOUN
globalce-157	57	23	of	of	ADP
globalce-157	57	24	the	the	DET
globalce-157	57	25	journal	journal	NOUN
globalce-157	57	26	papers	paper	NOUN
globalce-157	57	27	(	(	PUNCT
globalce-157	57	28	maude	maude	PROPN
globalce-157	57	29	database	database	NOUN
globalce-157	58	1	[	[	X
globalce-157	58	2	title	title	NOUN
globalce-157	58	3	/	/	SYM
globalce-157	58	4	abstract	abstract	NOUN
globalce-157	58	5	]	]	PUNCT
globalce-157	58	6	or	or	CCONJ
globalce-157	58	7	(	(	PUNCT
globalce-157	58	8	maude[title	maude[title	NOUN
globalce-157	58	9	/	/	SYM
globalce-157	58	10	abstract	abstract	ADJ
globalce-157	58	11	]	]	PUNCT
globalce-157	58	12	and	and	CCONJ
globalce-157	58	13	fda	fda	PROPN
globalce-157	59	1	[	[	X
globalce-157	59	2	title	title	NOUN
globalce-157	59	3	/	/	SYM
globalce-157	59	4	abstract	abstract	NOUN
globalce-157	59	5	]	]	X
globalce-157	59	6	)	)	PUNCT
globalce-157	59	7	)	)	PUNCT
globalce-157	59	8	.	.	PUNCT
globalce-157	60	1	the	the	DET
globalce-157	60	2	latter	latter	ADJ
globalce-157	60	3	broader	broad	ADJ
globalce-157	60	4	search	search	NOUN
globalce-157	60	5	was	be	AUX
globalce-157	60	6	performed	perform	VERB
globalce-157	60	7	to	to	PART
globalce-157	60	8	find	find	VERB
globalce-157	60	9	articles	article	NOUN
globalce-157	60	10	that	that	PRON
globalce-157	60	11	may	may	AUX
globalce-157	60	12	have	have	AUX
globalce-157	60	13	been	be	AUX
globalce-157	60	14	eluded	elude	VERB
globalce-157	60	15	from	from	ADP
globalce-157	60	16	the	the	DET
globalce-157	60	17	initial	initial	ADJ
globalce-157	60	18	query	query	NOUN
globalce-157	60	19	,	,	PUNCT
globalce-157	60	20	while	while	SCONJ
globalce-157	60	21	keeping	keep	VERB
globalce-157	60	22	their	their	PRON
globalce-157	60	23	content	content	NOUN
globalce-157	60	24	mainly	mainly	ADV
globalce-157	60	25	based	base	VERB
globalce-157	60	26	on	on	ADP
globalce-157	60	27	data	datum	NOUN
globalce-157	60	28	from	from	ADP
globalce-157	60	29	maude	maude	NOUN
globalce-157	60	30	and	and	CCONJ
globalce-157	60	31	excluding	exclude	VERB
globalce-157	60	32	ones	one	NOUN
globalce-157	60	33	with	with	ADP
globalce-157	60	34	simple	simple	ADJ
globalce-157	60	35	references	reference	NOUN
globalce-157	60	36	and	and	CCONJ
globalce-157	60	37	various	various	ADJ
globalce-157	60	38	irrelevant	irrelevant	ADJ
globalce-157	60	39	synonyms	synonym	NOUN
globalce-157	60	40	.	.	PUNCT
globalce-157	61	1	the	the	DET
globalce-157	61	2	final	final	ADJ
globalce-157	61	3	search	search	NOUN
globalce-157	61	4	yielded	yield	VERB
globalce-157	61	5	308	308	NUM
globalce-157	61	6	results	result	NOUN
globalce-157	61	7	up	up	ADP
globalce-157	61	8	to	to	ADP
globalce-157	61	9	2022	2022	NUM
globalce-157	61	10	(	(	PUNCT
globalce-157	61	11	figure	figure	NOUN
globalce-157	61	12	1	1	NUM
globalce-157	61	13	)	)	PUNCT
globalce-157	61	14	,	,	PUNCT
globalce-157	61	15	with	with	SCONJ
globalce-157	61	16	31	31	NUM
globalce-157	61	17	additional	additional	ADJ
globalce-157	61	18	articles	article	NOUN
globalce-157	61	19	been	be	AUX
globalce-157	61	20	published	publish	VERB
globalce-157	61	21	during	during	ADP
globalce-157	61	22	the	the	DET
globalce-157	61	23	first	first	ADJ
globalce-157	61	24	quarter	quarter	NOUN
globalce-157	61	25	of	of	ADP
globalce-157	61	26	2023	2023	NUM
globalce-157	61	27	.	.	PUNCT
globalce-157	62	1	most	most	ADJ
globalce-157	62	2	of	of	ADP
globalce-157	62	3	these	these	DET
globalce-157	62	4	studies	study	NOUN
globalce-157	62	5	analyze	analyze	VERB
globalce-157	62	6	adverse	adverse	ADJ
globalce-157	62	7	events	event	NOUN
globalce-157	62	8	for	for	ADP
globalce-157	62	9	specific	specific	ADJ
globalce-157	62	10	medical	medical	ADJ
globalce-157	62	11	device	device	NOUN
globalce-157	62	12	groups.9	groups.9	ADJ
globalce-157	62	13	recent	recent	ADJ
globalce-157	62	14	years	year	NOUN
globalce-157	62	15	examples	example	NOUN
globalce-157	62	16	involve	involve	VERB
globalce-157	62	17	mds	mds	NOUN
globalce-157	62	18	like	like	ADP
globalce-157	62	19	injectable	injectable	ADJ
globalce-157	62	20	fillers	filler	NOUN
globalce-157	62	21	,	,	PUNCT
globalce-157	62	22	deep	deep	ADJ
globalce-157	62	23	brain	brain	NOUN
globalce-157	62	24	stimulators	stimulator	NOUN
globalce-157	62	25	,	,	PUNCT
globalce-157	62	26	middle	middle	ADJ
globalce-157	62	27	ear	ear	NOUN
globalce-157	62	28	prostheses	prosthesis	NOUN
globalce-157	62	29	,	,	PUNCT
globalce-157	62	30	ossicular	ossicular	ADJ
globalce-157	62	31	prostheses	prosthesis	NOUN
globalce-157	62	32	and	and	CCONJ
globalce-157	62	33	catheters.10–14	catheters.10–14	NOUN
globalce-157	62	34	during	during	ADP
globalce-157	62	35	the	the	DET
globalce-157	62	36	last	last	ADJ
globalce-157	62	37	years	year	NOUN
globalce-157	62	38	,	,	PUNCT
globalce-157	62	39	a	a	DET
globalce-157	62	40	couple	couple	NOUN
globalce-157	62	41	of	of	ADP
globalce-157	62	42	studies	study	NOUN
globalce-157	62	43	analyzed	analyze	VERB
globalce-157	62	44	maude	maude	NOUN
globalce-157	62	45	data	datum	NOUN
globalce-157	62	46	taking	take	VERB
globalce-157	62	47	into	into	ADP
globalce-157	62	48	consideration	consideration	NOUN
globalce-157	62	49	the	the	DET
globalce-157	62	50	full	full	ADJ
globalce-157	62	51	spectrum	spectrum	NOUN
globalce-157	62	52	of	of	ADP
globalce-157	62	53	medical	medical	ADJ
globalce-157	62	54	device	device	NOUN
globalce-157	63	1	groups.15–17	groups.15–17	ADV
globalce-157	63	2	however	however	ADV
globalce-157	63	3	,	,	PUNCT
globalce-157	63	4	they	they	PRON
globalce-157	63	5	were	be	AUX
globalce-157	63	6	focused	focus	VERB
globalce-157	63	7	on	on	ADP
globalce-157	63	8	limited	limited	ADJ
globalce-157	63	9	aspects	aspect	NOUN
globalce-157	63	10	of	of	ADP
globalce-157	63	11	the	the	DET
globalce-157	63	12	available	available	ADJ
globalce-157	63	13	data	datum	NOUN
globalce-157	63	14	,	,	PUNCT
globalce-157	63	15	like	like	ADP
globalce-157	63	16	reporting	report	VERB
globalce-157	63	17	source	source	NOUN
globalce-157	63	18	and	and	CCONJ
globalce-157	63	19	reporter	reporter	NOUN
globalce-157	63	20	occupation	occupation	NOUN
globalce-157	63	21	,	,	PUNCT
globalce-157	63	22	and	and	CCONJ
globalce-157	63	23	they	they	PRON
globalce-157	63	24	were	be	AUX
globalce-157	63	25	published	publish	VERB
globalce-157	63	26	before	before	ADP
globalce-157	63	27	the	the	DET
globalce-157	63	28	boom	boom	NOUN
globalce-157	63	29	of	of	ADP
globalce-157	63	30	reports	report	NOUN
globalce-157	63	31	submitted	submit	VERB
globalce-157	63	32	to	to	ADP
globalce-157	63	33	maude	maude	NOUN
globalce-157	63	34	after	after	ADP
globalce-157	63	35	2019	2019	NUM
globalce-157	63	36	(	(	PUNCT
globalce-157	63	37	figure	figure	NOUN
globalce-157	63	38	2	2	NUM
globalce-157	63	39	)	)	PUNCT
globalce-157	63	40	.	.	PUNCT
globalce-157	64	1	the	the	DET
globalce-157	64	2	number	number	NOUN
globalce-157	64	3	of	of	ADP
globalce-157	64	4	studies	study	NOUN
globalce-157	64	5	mining	mine	VERB
globalce-157	64	6	the	the	DET
globalce-157	64	7	information	information	NOUN
globalce-157	64	8	used	use	VERB
globalce-157	64	9	from	from	ADP
globalce-157	64	10	maude	maude	PROPN
globalce-157	64	11	are	be	AUX
globalce-157	64	12	constantly	constantly	ADV
globalce-157	64	13	increasing	increase	VERB
globalce-157	64	14	during	during	ADP
globalce-157	64	15	the	the	DET
globalce-157	64	16	last	last	ADJ
globalce-157	64	17	ten	ten	NUM
globalce-157	64	18	years	year	NOUN
globalce-157	64	19	and	and	CCONJ
globalce-157	64	20	provide	provide	VERB
globalce-157	64	21	very	very	ADV
globalce-157	64	22	valuable	valuable	ADJ
globalce-157	64	23	insights	insight	NOUN
globalce-157	64	24	on	on	ADP
globalce-157	64	25	safety	safety	NOUN
globalce-157	64	26	b	b	PROPN
globalce-157	64	27	https://ec.europa.eu/docsroom/documents/32305	https://ec.europa.eu/docsroom/documents/32305	NOUN
globalce-157	64	28	c	c	NOUN
globalce-157	64	29	ttps://ec.europa.eu/docsroom/documents/32305	ttps://ec.europa.eu/docsroom/documents/32305	PROPN
globalce-157	64	30	figure	figure	NOUN
globalce-157	64	31	1	1	NUM
globalce-157	64	32	.	.	PUNCT
globalce-157	64	33	pubmed	pubmed	PROPN
globalce-157	64	34	articles	article	NOUN
globalce-157	64	35	with	with	ADP
globalce-157	64	36	relevant	relevant	ADJ
globalce-157	64	37	maude	maude	NOUN
globalce-157	64	38	terms	term	NOUN
globalce-157	64	39	in	in	ADP
globalce-157	64	40	title	title	NOUN
globalce-157	64	41	/	/	SYM
globalce-157	64	42	abstract	abstract	ADJ
globalce-157	64	43	.	.	PUNCT
globalce-157	65	1	https://ec.europa.eu/docsroom/documents/32305	https://ec.europa.eu/docsroom/documents/32305	NOUN
globalce-157	65	2	ttps://ec.europa.eu/docsroom/documents/32305	ttps://ec.europa.eu/docsroom/documents/32305	PROPN
globalce-157	65	3	zisimopoulos	zisimopoulo	NOUN
globalce-157	65	4	,	,	PUNCT
globalce-157	65	5	pallikarakis	pallikarakis	PROPN
globalce-157	65	6	:	:	PUNCT
globalce-157	65	7	an	an	DET
globalce-157	65	8	analysis	analysis	NOUN
globalce-157	65	9	of	of	ADP
globalce-157	65	10	adverse	adverse	ADJ
globalce-157	65	11	event	event	NOUN
globalce-157	65	12	reports	report	NOUN
globalce-157	65	13	in	in	ADP
globalce-157	65	14	fda	fda	PROPN
globalce-157	65	15	’s	’s	PART
globalce-157	65	16	maude	maude	PROPN
globalce-157	65	17	database	database	PROPN
globalce-157	65	18	j	j	PROPN
globalce-157	66	1	global	global	ADJ
globalce-157	66	2	clinical	clinical	ADJ
globalce-157	66	3	engineering	engineering	PROPN
globalce-157	66	4	vol.6	vol.6	PROPN
globalce-157	66	5	issue	issue	NOUN
globalce-157	66	6	1	1	NUM
globalce-157	66	7	:	:	SYM
globalce-157	66	8	2023	2023	NUM
globalce-157	66	9	8	8	NUM
globalce-157	66	10	issues	issue	NOUN
globalce-157	66	11	concerning	concern	VERB
globalce-157	66	12	mds	mds	PROPN
globalce-157	66	13	.	.	PUNCT
globalce-157	67	1	this	this	DET
globalce-157	67	2	trend	trend	NOUN
globalce-157	67	3	was	be	AUX
globalce-157	67	4	reported	report	VERB
globalce-157	67	5	in	in	ADP
globalce-157	67	6	a	a	DET
globalce-157	67	7	study	study	NOUN
globalce-157	67	8	by	by	ADP
globalce-157	67	9	p.	p.	PROPN
globalce-157	67	10	malataras	malataras	PROPN
globalce-157	67	11	and	and	CCONJ
globalce-157	67	12	n.	n.	PROPN
globalce-157	67	13	pallikarakis	pallikarakis	PROPN
globalce-157	67	14	,	,	PUNCT
globalce-157	67	15	regarding	regard	VERB
globalce-157	67	16	the	the	DET
globalce-157	67	17	use	use	NOUN
globalce-157	67	18	of	of	ADP
globalce-157	67	19	maude	maude	PROPN
globalce-157	67	20	’s	’s	PART
globalce-157	67	21	data	datum	NOUN
globalce-157	67	22	in	in	ADP
globalce-157	67	23	research	research	NOUN
globalce-157	67	24	between	between	ADP
globalce-157	67	25	the	the	DET
globalce-157	67	26	years	year	NOUN
globalce-157	67	27	2005	2005	NUM
globalce-157	67	28	and	and	CCONJ
globalce-157	67	29	2014,9	2014,9	NUM
globalce-157	67	30	where	where	SCONJ
globalce-157	67	31	a	a	DET
globalce-157	67	32	linear	linear	ADJ
globalce-157	67	33	increase	increase	NOUN
globalce-157	67	34	of	of	ADP
globalce-157	67	35	papers	paper	NOUN
globalce-157	67	36	published	publish	VERB
globalce-157	67	37	each	each	DET
globalce-157	67	38	year	year	NOUN
globalce-157	67	39	was	be	AUX
globalce-157	67	40	showcased	showcase	VERB
globalce-157	67	41	.	.	PUNCT
globalce-157	68	1	to	to	PART
globalce-157	68	2	add	add	VERB
globalce-157	68	3	into	into	ADP
globalce-157	68	4	that	that	PRON
globalce-157	68	5	,	,	PUNCT
globalce-157	68	6	a	a	DET
globalce-157	68	7	sharp	sharp	ADJ
globalce-157	68	8	increase	increase	NOUN
globalce-157	68	9	of	of	ADP
globalce-157	68	10	publications	publication	NOUN
globalce-157	68	11	has	have	AUX
globalce-157	68	12	been	be	AUX
globalce-157	68	13	observed	observe	VERB
globalce-157	68	14	in	in	ADP
globalce-157	68	15	the	the	DET
globalce-157	68	16	last	last	ADJ
globalce-157	68	17	couple	couple	NOUN
globalce-157	68	18	of	of	ADP
globalce-157	68	19	years	year	NOUN
globalce-157	68	20	,	,	PUNCT
globalce-157	68	21	highlighting	highlight	VERB
globalce-157	68	22	the	the	DET
globalce-157	68	23	developing	develop	VERB
globalce-157	68	24	interest	interest	NOUN
globalce-157	68	25	in	in	ADP
globalce-157	68	26	utilizing	utilize	VERB
globalce-157	68	27	fda	fda	PROPN
globalce-157	68	28	’s	’s	PROPN
globalce-157	68	29	maude	maude	PROPN
globalce-157	68	30	data	datum	NOUN
globalce-157	68	31	as	as	SCONJ
globalce-157	68	32	shown	show	VERB
globalce-157	68	33	in	in	ADP
globalce-157	68	34	figure	figure	NOUN
globalce-157	68	35	2	2	NUM
globalce-157	68	36	.	.	PUNCT
globalce-157	69	1	materials	material	NOUN
globalce-157	69	2	&	&	CCONJ
globalce-157	69	3	methods	method	NOUN
globalce-157	69	4	the	the	DET
globalce-157	69	5	maude	maude	PROPN
globalce-157	69	6	database	database	NOUN
globalce-157	69	7	was	be	AUX
globalce-157	69	8	used	use	VERB
globalce-157	69	9	for	for	ADP
globalce-157	69	10	the	the	DET
globalce-157	69	11	analysis	analysis	NOUN
globalce-157	69	12	performed	perform	VERB
globalce-157	69	13	in	in	ADP
globalce-157	69	14	this	this	DET
globalce-157	69	15	study	study	NOUN
globalce-157	69	16	.	.	PUNCT
globalce-157	70	1	of	of	ADP
globalce-157	70	2	all	all	DET
globalce-157	70	3	the	the	DET
globalce-157	70	4	afore	afore	ADV
globalce-157	70	5	-	-	PUNCT
globalce-157	70	6	mentioned	mention	VERB
globalce-157	70	7	adverse	adverse	ADJ
globalce-157	70	8	event	event	NOUN
globalce-157	70	9	report	report	VERB
globalce-157	70	10	databases	database	NOUN
globalce-157	70	11	,	,	PUNCT
globalce-157	70	12	maude	maude	NOUN
globalce-157	70	13	is	be	AUX
globalce-157	70	14	the	the	DET
globalce-157	70	15	best	well	ADV
globalce-157	70	16	structured	structured	ADJ
globalce-157	70	17	and	and	CCONJ
globalce-157	70	18	most	most	ADV
globalce-157	70	19	complete	complete	ADJ
globalce-157	70	20	,	,	PUNCT
globalce-157	70	21	with	with	ADP
globalce-157	70	22	data	datum	NOUN
globalce-157	70	23	ranging	range	VERB
globalce-157	70	24	from	from	ADP
globalce-157	70	25	1991	1991	NUM
globalce-157	70	26	to	to	ADP
globalce-157	70	27	date	date	NOUN
globalce-157	70	28	.	.	PUNCT
globalce-157	71	1	furthermore	furthermore	ADV
globalce-157	71	2	,	,	PUNCT
globalce-157	71	3	it	it	PRON
globalce-157	71	4	can	can	AUX
globalce-157	71	5	be	be	AUX
globalce-157	71	6	easily	easily	ADV
globalce-157	71	7	accessed	access	VERB
globalce-157	71	8	and	and	CCONJ
globalce-157	71	9	has	have	AUX
globalce-157	71	10	been	be	AUX
globalce-157	71	11	used	use	VERB
globalce-157	71	12	in	in	ADP
globalce-157	71	13	other	other	ADJ
globalce-157	71	14	studies	study	NOUN
globalce-157	71	15	in	in	ADP
globalce-157	71	16	the	the	DET
globalce-157	71	17	past	past	NOUN
globalce-157	71	18	.	.	PUNCT
globalce-157	72	1	data	datum	NOUN
globalce-157	72	2	processing	processing	NOUN
globalce-157	72	3	and	and	CCONJ
globalce-157	72	4	analysis	analysis	NOUN
globalce-157	72	5	was	be	AUX
globalce-157	72	6	performed	perform	VERB
globalce-157	72	7	using	use	VERB
globalce-157	72	8	the	the	DET
globalce-157	72	9	jupyter	jupyter	ADJ
globalce-157	72	10	notebook	notebook	NOUN
globalce-157	72	11	web	web	NOUN
globalce-157	72	12	application	application	NOUN
globalce-157	72	13	,	,	PUNCT
globalce-157	72	14	along	along	ADP
globalce-157	72	15	with	with	ADP
globalce-157	72	16	the	the	DET
globalce-157	72	17	python	python	NOUN
globalce-157	72	18	data	datum	NOUN
globalce-157	72	19	analysis	analysis	NOUN
globalce-157	72	20	(	(	PUNCT
globalce-157	72	21	pandas	panda	NOUN
globalce-157	72	22	)	)	PUNCT
globalce-157	72	23	and	and	CCONJ
globalce-157	72	24	numerical	numerical	PROPN
globalce-157	72	25	python	python	PROPN
globalce-157	72	26	(	(	PUNCT
globalce-157	72	27	numpy	numpy	NOUN
globalce-157	72	28	)	)	PUNCT
globalce-157	72	29	libraries	library	NOUN
globalce-157	72	30	.	.	PUNCT
globalce-157	73	1	data	datum	NOUN
globalce-157	73	2	acquisition	acquisition	NOUN
globalce-157	73	3	and	and	CCONJ
globalce-157	73	4	pre	pre	ADJ
globalce-157	73	5	-	-	ADJ
globalce-157	73	6	processing	process	VERB
globalce-157	73	7	all	all	DET
globalce-157	73	8	data	datum	NOUN
globalce-157	73	9	used	use	VERB
globalce-157	73	10	in	in	ADP
globalce-157	73	11	this	this	DET
globalce-157	73	12	study	study	NOUN
globalce-157	73	13	are	be	AUX
globalce-157	73	14	publicly	publicly	ADV
globalce-157	73	15	available	available	ADJ
globalce-157	73	16	on	on	ADP
globalce-157	73	17	fda	fda	PROPN
globalce-157	73	18	’s	’s	PART
globalce-157	73	19	maude	maude	PROPN
globalce-157	73	20	page.2	page.2	PROPN
globalce-157	73	21	data	datum	NOUN
globalce-157	73	22	available	available	ADJ
globalce-157	73	23	in	in	ADP
globalce-157	73	24	maude	maude	PROPN
globalce-157	73	25	span	span	NOUN
globalce-157	73	26	from	from	ADP
globalce-157	73	27	1991	1991	NUM
globalce-157	73	28	up	up	ADP
globalce-157	73	29	to	to	ADP
globalce-157	73	30	2022	2022	NUM
globalce-157	73	31	(	(	PUNCT
globalce-157	73	32	user	user	NOUN
globalce-157	73	33	facility	facility	NOUN
globalce-157	73	34	reports	report	NOUN
globalce-157	73	35	since	since	SCONJ
globalce-157	73	36	1991	1991	NUM
globalce-157	73	37	,	,	PUNCT
globalce-157	73	38	distributor	distributor	NOUN
globalce-157	73	39	and	and	CCONJ
globalce-157	73	40	voluntary	voluntary	ADJ
globalce-157	73	41	reports	report	NOUN
globalce-157	73	42	since	since	SCONJ
globalce-157	73	43	1993	1993	NUM
globalce-157	73	44	and	and	CCONJ
globalce-157	73	45	manufacturer	manufacturer	NOUN
globalce-157	73	46	reports	report	NOUN
globalce-157	73	47	since	since	SCONJ
globalce-157	73	48	1996	1996	NUM
globalce-157	73	49	)	)	PUNCT
globalce-157	73	50	.	.	PUNCT
globalce-157	74	1	for	for	ADP
globalce-157	74	2	the	the	DET
globalce-157	74	3	remainder	remainder	NOUN
globalce-157	74	4	of	of	ADP
globalce-157	74	5	this	this	DET
globalce-157	74	6	work	work	NOUN
globalce-157	74	7	,	,	PUNCT
globalce-157	74	8	data	datum	NOUN
globalce-157	74	9	referring	refer	VERB
globalce-157	74	10	to	to	ADP
globalce-157	74	11	the	the	DET
globalce-157	74	12	year	year	NOUN
globalce-157	74	13	1997	1997	NUM
globalce-157	74	14	will	will	AUX
globalce-157	74	15	consist	consist	VERB
globalce-157	74	16	of	of	ADP
globalce-157	74	17	events	event	NOUN
globalce-157	74	18	reported	report	VERB
globalce-157	74	19	between	between	ADP
globalce-157	74	20	1991	1991	NUM
globalce-157	74	21	up	up	ADP
globalce-157	74	22	to	to	ADP
globalce-157	74	23	1997	1997	NUM
globalce-157	74	24	,	,	PUNCT
globalce-157	74	25	according	accord	VERB
globalce-157	74	26	to	to	ADP
globalce-157	74	27	maude	maude	PROPN
globalce-157	74	28	’s	’s	PART
globalce-157	74	29	“	"	PUNCT
globalce-157	74	30	foidevthru1997	foidevthru1997	PROPN
globalce-157	74	31	”	"	PUNCT
globalce-157	74	32	file	file	NOUN
globalce-157	74	33	.	.	PUNCT
globalce-157	75	1	data	datum	NOUN
globalce-157	75	2	regarding	regard	VERB
globalce-157	75	3	2022	2022	NUM
globalce-157	75	4	contains	contain	VERB
globalce-157	75	5	reports	report	NOUN
globalce-157	75	6	that	that	PRON
globalce-157	75	7	were	be	AUX
globalce-157	75	8	available	available	ADJ
globalce-157	75	9	on	on	ADP
globalce-157	75	10	maude	maude	PROPN
globalce-157	75	11	until	until	ADP
globalce-157	75	12	4/11/2022	4/11/2022	PROPN
globalce-157	75	13	,	,	PUNCT
globalce-157	75	14	due	due	ADP
globalce-157	75	15	to	to	ADP
globalce-157	75	16	the	the	DET
globalce-157	75	17	time	time	NOUN
globalce-157	75	18	of	of	ADP
globalce-157	75	19	research	research	NOUN
globalce-157	75	20	.	.	PUNCT
globalce-157	76	1	for	for	ADP
globalce-157	76	2	the	the	DET
globalce-157	76	3	remainder	remainder	NOUN
globalce-157	76	4	of	of	ADP
globalce-157	76	5	the	the	DET
globalce-157	76	6	work	work	NOUN
globalce-157	76	7	,	,	PUNCT
globalce-157	76	8	data	data	VERB
globalce-157	76	9	up	up	ADP
globalce-157	76	10	to	to	ADP
globalce-157	76	11	4/11/2022	4/11/2022	NOUN
globalce-157	76	12	will	will	AUX
globalce-157	76	13	be	be	AUX
globalce-157	76	14	referred	refer	VERB
globalce-157	76	15	to	to	ADP
globalce-157	76	16	as	as	ADP
globalce-157	76	17	data	datum	NOUN
globalce-157	76	18	for	for	ADP
globalce-157	76	19	the	the	DET
globalce-157	76	20	year	year	NOUN
globalce-157	76	21	2022	2022	NUM
globalce-157	76	22	.	.	PUNCT
globalce-157	77	1	device	device	NOUN
globalce-157	77	2	information	information	NOUN
globalce-157	77	3	associated	associate	VERB
globalce-157	77	4	with	with	ADP
globalce-157	77	5	an	an	DET
globalce-157	77	6	event	event	NOUN
globalce-157	77	7	was	be	AUX
globalce-157	77	8	taken	take	VERB
globalce-157	77	9	from	from	ADP
globalce-157	77	10	the	the	DET
globalce-157	77	11	available	available	ADJ
globalce-157	77	12	“	"	PUNCT
globalce-157	77	13	foidevxxxx	foidevxxxx	NOUN
globalce-157	77	14	”	"	PUNCT
globalce-157	77	15	and	and	CCONJ
globalce-157	77	16	“	"	PUNCT
globalce-157	77	17	devicexxxx	devicexxxx	NOUN
globalce-157	77	18	”	"	PUNCT
globalce-157	77	19	files	file	NOUN
globalce-157	77	20	,	,	PUNCT
globalce-157	77	21	were	be	AUX
globalce-157	77	22	xxxx	xxxx	ADJ
globalce-157	77	23	annotates	annotate	NOUN
globalce-157	77	24	the	the	DET
globalce-157	77	25	year	year	NOUN
globalce-157	77	26	.	.	PUNCT
globalce-157	78	1	information	information	NOUN
globalce-157	78	2	about	about	ADP
globalce-157	78	3	the	the	DET
globalce-157	78	4	adverse	adverse	ADJ
globalce-157	78	5	event	event	NOUN
globalce-157	78	6	was	be	AUX
globalce-157	78	7	found	find	VERB
globalce-157	78	8	in	in	ADP
globalce-157	78	9	the	the	DET
globalce-157	78	10	files	file	NOUN
globalce-157	78	11	named	name	VERB
globalce-157	78	12	“	"	PUNCT
globalce-157	78	13	mdrfoithru2021	mdrfoithru2021	PROPN
globalce-157	78	14	”	"	PUNCT
globalce-157	78	15	,	,	PUNCT
globalce-157	78	16	which	which	PRON
globalce-157	78	17	contains	contain	VERB
globalce-157	78	18	data	datum	NOUN
globalce-157	78	19	from	from	ADP
globalce-157	78	20	inception	inception	NOUN
globalce-157	78	21	up	up	ADP
globalce-157	78	22	to	to	ADP
globalce-157	78	23	2021	2021	NUM
globalce-157	78	24	and	and	CCONJ
globalce-157	78	25	“	"	PUNCT
globalce-157	78	26	mdrfoi	mdrfoi	PROPN
globalce-157	78	27	”	"	PUNCT
globalce-157	78	28	,	,	PUNCT
globalce-157	78	29	which	which	PRON
globalce-157	78	30	contains	contain	VERB
globalce-157	78	31	data	datum	NOUN
globalce-157	78	32	of	of	ADP
globalce-157	78	33	the	the	DET
globalce-157	78	34	present	present	ADJ
globalce-157	78	35	year	year	NOUN
globalce-157	78	36	(	(	PUNCT
globalce-157	78	37	i.e.	i.e.	X
globalce-157	78	38	,	,	PUNCT
globalce-157	78	39	2022	2022	NUM
globalce-157	78	40	)	)	PUNCT
globalce-157	78	41	.	.	PUNCT
globalce-157	79	1	the	the	DET
globalce-157	79	2	device	device	NOUN
globalce-157	79	3	and	and	CCONJ
globalce-157	79	4	mdrfoi	mdrfoi	VERB
globalce-157	79	5	files	file	NOUN
globalce-157	79	6	were	be	AUX
globalce-157	79	7	joined	join	VERB
globalce-157	79	8	together	together	ADV
globalce-157	79	9	using	use	VERB
globalce-157	79	10	the	the	DET
globalce-157	79	11	“	"	PUNCT
globalce-157	79	12	mdr_report_key	mdr_report_key	ADJ
globalce-157	79	13	”	"	PUNCT
globalce-157	79	14	field	field	NOUN
globalce-157	79	15	as	as	ADP
globalce-157	79	16	primary	primary	ADJ
globalce-157	79	17	key	key	NOUN
globalce-157	79	18	.	.	PUNCT
globalce-157	80	1	data	datum	NOUN
globalce-157	80	2	pre	pre	ADJ
globalce-157	80	3	-	-	VERB
globalce-157	80	4	processing	process	VERB
globalce-157	80	5	a	a	DET
globalce-157	80	6	total	total	ADJ
globalce-157	80	7	mdrfoi	mdrfoi	NOUN
globalce-157	80	8	dataframe	dataframe	PROPN
globalce-157	80	9	was	be	AUX
globalce-157	80	10	created	create	VERB
globalce-157	80	11	by	by	ADP
globalce-157	80	12	merging	merge	VERB
globalce-157	80	13	the	the	DET
globalce-157	80	14	“	"	PUNCT
globalce-157	80	15	mdrfoithru2021	mdrfoithru2021	PROPN
globalce-157	80	16	”	"	PUNCT
globalce-157	80	17	and	and	CCONJ
globalce-157	80	18	“	"	PUNCT
globalce-157	80	19	mdrfoi	mdrfoi	VERB
globalce-157	80	20	”	"	PUNCT
globalce-157	80	21	files	file	NOUN
globalce-157	80	22	.	.	PUNCT
globalce-157	81	1	after	after	ADP
globalce-157	81	2	data	datum	NOUN
globalce-157	81	3	cleaning	clean	VERB
globalce-157	81	4	by	by	ADP
globalce-157	81	5	deleting	delete	VERB
globalce-157	81	6	rows	row	NOUN
globalce-157	81	7	with	with	ADP
globalce-157	81	8	wrong	wrong	ADJ
globalce-157	81	9	field	field	NOUN
globalce-157	81	10	format	format	NOUN
globalce-157	81	11	,	,	PUNCT
globalce-157	81	12	wrong	wrong	ADJ
globalce-157	81	13	delimiter	delimiter	NOUN
globalce-157	81	14	,	,	PUNCT
globalce-157	81	15	unreadable	unreadable	ADJ
globalce-157	81	16	characters	character	NOUN
globalce-157	81	17	,	,	PUNCT
globalce-157	81	18	duplicate	duplicate	VERB
globalce-157	81	19	key	key	ADJ
globalce-157	81	20	values	value	NOUN
globalce-157	81	21	etc	etc	X
globalce-157	81	22	.	.	X
globalce-157	81	23	15,387,348	15,387,348	NUM
globalce-157	81	24	lines	line	NOUN
globalce-157	81	25	of	of	ADP
globalce-157	81	26	data	datum	NOUN
globalce-157	81	27	remained	remain	VERB
globalce-157	81	28	.	.	PUNCT
globalce-157	82	1	the	the	DET
globalce-157	82	2	same	same	ADJ
globalce-157	82	3	process	process	NOUN
globalce-157	82	4	was	be	AUX
globalce-157	82	5	carried	carry	VERB
globalce-157	82	6	out	out	ADP
globalce-157	82	7	for	for	ADP
globalce-157	82	8	all	all	DET
globalce-157	82	9	“	"	PUNCT
globalce-157	82	10	devicexxxx	devicexxxx	NOUN
globalce-157	82	11	”	"	PUNCT
globalce-157	82	12	files	file	NOUN
globalce-157	82	13	,	,	PUNCT
globalce-157	82	14	and	and	CCONJ
globalce-157	82	15	a	a	DET
globalce-157	82	16	total	total	ADJ
globalce-157	82	17	device	device	NOUN
globalce-157	82	18	dataframe	dataframe	ADJ
globalce-157	82	19	was	be	AUX
globalce-157	82	20	created	create	VERB
globalce-157	82	21	containing	contain	VERB
globalce-157	82	22	15,386,069	15,386,069	NUM
globalce-157	82	23	lines	line	NOUN
globalce-157	82	24	of	of	ADP
globalce-157	82	25	data	datum	NOUN
globalce-157	82	26	.	.	PUNCT
globalce-157	83	1	after	after	ADP
globalce-157	83	2	merging	merge	VERB
globalce-157	83	3	these	these	DET
globalce-157	83	4	mdrfoi	mdrfoi	NOUN
globalce-157	83	5	and	and	CCONJ
globalce-157	83	6	device	device	NOUN
globalce-157	83	7	dataframes	dataframe	NOUN
globalce-157	83	8	,	,	PUNCT
globalce-157	83	9	using	use	VERB
globalce-157	83	10	the	the	DET
globalce-157	83	11	mdr	mdr	PROPN
globalce-157	83	12	report	report	PROPN
globalce-157	83	13	key	key	ADJ
globalce-157	83	14	value	value	NOUN
globalce-157	83	15	as	as	ADP
globalce-157	83	16	primary	primary	ADJ
globalce-157	83	17	key	key	NOUN
globalce-157	83	18	,	,	PUNCT
globalce-157	83	19	a	a	DET
globalce-157	83	20	final	final	ADJ
globalce-157	83	21	dataframe	dataframe	NOUN
globalce-157	83	22	with	with	ADP
globalce-157	83	23	15,343,314	15,343,314	NUM
globalce-157	83	24	lines	line	NOUN
globalce-157	83	25	of	of	ADP
globalce-157	83	26	data	datum	NOUN
globalce-157	83	27	was	be	AUX
globalce-157	83	28	created	create	VERB
globalce-157	83	29	,	,	PUNCT
globalce-157	83	30	upon	upon	SCONJ
globalce-157	83	31	which	which	PRON
globalce-157	83	32	the	the	DET
globalce-157	83	33	analysis	analysis	NOUN
globalce-157	83	34	of	of	ADP
globalce-157	83	35	adverse	adverse	ADJ
globalce-157	83	36	event	event	NOUN
globalce-157	83	37	reports	report	NOUN
globalce-157	83	38	was	be	AUX
globalce-157	83	39	carried	carry	VERB
globalce-157	83	40	out	out	ADP
globalce-157	83	41	.	.	PUNCT
globalce-157	84	1	event	event	NOUN
globalce-157	84	2	outcomes	outcome	NOUN
globalce-157	84	3	all	all	DET
globalce-157	84	4	adverse	adverse	ADJ
globalce-157	84	5	event	event	NOUN
globalce-157	84	6	reports	report	NOUN
globalce-157	84	7	available	available	ADJ
globalce-157	84	8	on	on	ADP
globalce-157	84	9	maude	maude	PROPN
globalce-157	84	10	were	be	AUX
globalce-157	84	11	analyzed	analyze	VERB
globalce-157	84	12	under	under	ADP
globalce-157	84	13	the	the	DET
globalce-157	84	14	scope	scope	NOUN
globalce-157	84	15	of	of	ADP
globalce-157	84	16	various	various	ADJ
globalce-157	84	17	event	event	NOUN
globalce-157	84	18	outcomes	outcome	NOUN
globalce-157	84	19	.	.	PUNCT
globalce-157	85	1	using	use	VERB
globalce-157	85	2	the	the	DET
globalce-157	85	3	various	various	ADJ
globalce-157	85	4	outcome	outcome	NOUN
globalce-157	85	5	codes	code	NOUN
globalce-157	85	6	presented	present	VERB
globalce-157	85	7	below	below	ADV
globalce-157	85	8	as	as	ADP
globalce-157	85	9	queries	query	NOUN
globalce-157	85	10	,	,	PUNCT
globalce-157	85	11	the	the	DET
globalce-157	85	12	data	datum	NOUN
globalce-157	85	13	are	be	AUX
globalce-157	85	14	organized	organize	VERB
globalce-157	85	15	and	and	CCONJ
globalce-157	85	16	presented	present	VERB
globalce-157	85	17	as	as	ADP
globalce-157	85	18	histograms	histogram	NOUN
globalce-157	85	19	of	of	ADP
globalce-157	85	20	number	number	NOUN
globalce-157	85	21	of	of	ADP
globalce-157	85	22	reports	report	NOUN
globalce-157	85	23	for	for	ADP
globalce-157	85	24	each	each	DET
globalce-157	85	25	year	year	NOUN
globalce-157	85	26	until	until	ADP
globalce-157	85	27	2022	2022	NUM
globalce-157	85	28	.	.	PUNCT
globalce-157	86	1	outcomes	outcome	NOUN
globalce-157	86	2	included	include	VERB
globalce-157	86	3	whether	whether	SCONJ
globalce-157	86	4	the	the	DET
globalce-157	86	5	device	device	NOUN
globalce-157	86	6	was	be	AUX
globalce-157	86	7	evaluated	evaluate	VERB
globalce-157	86	8	by	by	ADP
globalce-157	86	9	the	the	DET
globalce-157	86	10	manufacturer	manufacturer	NOUN
globalce-157	86	11	,	,	PUNCT
globalce-157	86	12	event	event	NOUN
globalce-157	86	13	type	type	NOUN
globalce-157	86	14	,	,	PUNCT
globalce-157	86	15	remedial	remedial	ADJ
globalce-157	86	16	action	action	NOUN
globalce-157	86	17	,	,	PUNCT
globalce-157	86	18	problem	problem	NOUN
globalce-157	86	19	code	code	NOUN
globalce-157	86	20	,	,	PUNCT
globalce-157	86	21	and	and	CCONJ
globalce-157	86	22	device	device	NOUN
globalce-157	86	23	age	age	NOUN
globalce-157	86	24	(	(	PUNCT
globalce-157	86	25	year	year	NOUN
globalce-157	86	26	of	of	ADP
globalce-157	86	27	report	report	NOUN
globalce-157	86	28	minus	minus	ADP
globalce-157	86	29	year	year	NOUN
globalce-157	86	30	of	of	ADP
globalce-157	86	31	manufacture	manufacture	NOUN
globalce-157	86	32	)	)	PUNCT
globalce-157	86	33	.	.	PUNCT
globalce-157	87	1	event	event	NOUN
globalce-157	87	2	type	type	VERB
globalce-157	87	3	the	the	DET
globalce-157	87	4	event	event	NOUN
globalce-157	87	5	type	type	NOUN
globalce-157	87	6	(	(	PUNCT
globalce-157	87	7	h1	h1	VERB
globalce-157	87	8	field	field	NOUN
globalce-157	87	9	on	on	ADP
globalce-157	87	10	the	the	DET
globalce-157	87	11	3500a	3500a	NUM
globalce-157	87	12	form	form	NOUN
globalce-157	87	13	)	)	PUNCT
globalce-157	87	14	is	be	AUX
globalce-157	87	15	used	use	VERB
globalce-157	87	16	to	to	PART
globalce-157	87	17	describe	describe	VERB
globalce-157	87	18	the	the	DET
globalce-157	87	19	impact	impact	NOUN
globalce-157	87	20	of	of	ADP
globalce-157	87	21	adverse	adverse	ADJ
globalce-157	87	22	events	event	NOUN
globalce-157	87	23	.	.	PUNCT
globalce-157	88	1	it	it	PRON
globalce-157	88	2	is	be	AUX
globalce-157	88	3	only	only	ADV
globalce-157	88	4	considered	consider	VERB
globalce-157	88	5	relevant	relevant	ADJ
globalce-157	88	6	by	by	ADP
globalce-157	88	7	the	the	DET
globalce-157	88	8	fda	fda	PROPN
globalce-157	88	9	when	when	SCONJ
globalce-157	88	10	the	the	DET
globalce-157	88	11	reporter	reporter	NOUN
globalce-157	88	12	of	of	ADP
globalce-157	88	13	the	the	DET
globalce-157	88	14	event	event	NOUN
globalce-157	88	15	is	be	AUX
globalce-157	88	16	a	a	DET
globalce-157	88	17	manufacturer	manufacturer	NOUN
globalce-157	88	18	and	and	CCONJ
globalce-157	88	19	makes	make	VERB
globalce-157	88	20	use	use	NOUN
globalce-157	88	21	of	of	ADP
globalce-157	88	22	the	the	DET
globalce-157	88	23	following	follow	VERB
globalce-157	88	24	codes	code	NOUN
globalce-157	88	25	:	:	PUNCT
globalce-157	88	26	figure	figure	NOUN
globalce-157	88	27	2	2	NUM
globalce-157	88	28	.	.	PUNCT
globalce-157	88	29	annual	annual	ADJ
globalce-157	88	30	maude	maude	PROPN
globalce-157	88	31	adverse	adverse	ADJ
globalce-157	88	32	event	event	NOUN
globalce-157	88	33	reports	report	VERB
globalce-157	88	34	.	.	PUNCT
globalce-157	89	1	data	datum	NOUN
globalce-157	89	2	until	until	ADP
globalce-157	89	3	4/11/2022	4/11/2022	PROPN
globalce-157	89	4	9	9	NUM
globalce-157	89	5	j	j	PROPN
globalce-157	89	6	global	global	ADJ
globalce-157	89	7	clinical	clinical	ADJ
globalce-157	89	8	engineering	engineering	PROPN
globalce-157	89	9	vol.6	vol.6	PROPN
globalce-157	89	10	issue	issue	NOUN
globalce-157	89	11	1	1	NUM
globalce-157	89	12	:	:	SYM
globalce-157	89	13	2023	2023	NUM
globalce-157	89	14	zisimopoulos	zisimopoulo	NOUN
globalce-157	89	15	,	,	PUNCT
globalce-157	89	16	pallikarakis	pallikarakis	PROPN
globalce-157	89	17	:	:	PUNCT
globalce-157	89	18	an	an	DET
globalce-157	89	19	analysis	analysis	NOUN
globalce-157	89	20	of	of	ADP
globalce-157	89	21	adverse	adverse	ADJ
globalce-157	89	22	event	event	NOUN
globalce-157	89	23	reports	report	NOUN
globalce-157	89	24	in	in	ADP
globalce-157	89	25	fda	fda	PROPN
globalce-157	89	26	’s	’s	PART
globalce-157	89	27	maude	maude	PROPN
globalce-157	89	28	database	database	PROPN
globalce-157	89	29	d	d	X
globalce-157	89	30	=	=	SYM
globalce-157	89	31	death	death	NOUN
globalce-157	89	32	,	,	PUNCT
globalce-157	89	33	{	{	PUNCT
globalce-157	89	34	in	in	ADP
globalce-157	89	35	,	,	PUNCT
globalce-157	89	36	il	il	PROPN
globalce-157	89	37	,	,	PUNCT
globalce-157	89	38	ij	ij	INTJ
globalce-157	89	39	}	}	PUNCT
globalce-157	89	40	=	=	SYM
globalce-157	89	41	injury	injury	NOUN
globalce-157	89	42	,	,	PUNCT
globalce-157	89	43	m	m	PROPN
globalce-157	89	44	=	=	NOUN
globalce-157	89	45	malfunction	malfunction	NOUN
globalce-157	89	46	,	,	PUNCT
globalce-157	89	47	o	o	NOUN
globalce-157	90	1	=	=	PUNCT
globalce-157	90	2	other	other	ADJ
globalce-157	90	3	,	,	PUNCT
globalce-157	90	4	{	{	PUNCT
globalce-157	90	5	blank}=	blank}=	NOUN
globalce-157	90	6	no	no	DET
globalce-157	90	7	answer	answer	NOUN
globalce-157	90	8	provided	provide	VERB
globalce-157	90	9	.	.	PUNCT
globalce-157	91	1	only	only	ADV
globalce-157	91	2	one	one	NUM
globalce-157	91	3	code	code	NOUN
globalce-157	91	4	may	may	AUX
globalce-157	91	5	be	be	AUX
globalce-157	91	6	used	use	VERB
globalce-157	91	7	for	for	ADP
globalce-157	91	8	each	each	DET
globalce-157	91	9	event	event	NOUN
globalce-157	91	10	.	.	PUNCT
globalce-157	92	1	a	a	DET
globalce-157	92	2	malfunction	malfunction	NOUN
globalce-157	92	3	refers	refer	VERB
globalce-157	92	4	to	to	ADP
globalce-157	92	5	an	an	DET
globalce-157	92	6	adverse	adverse	ADJ
globalce-157	92	7	event	event	NOUN
globalce-157	92	8	where	where	SCONJ
globalce-157	92	9	the	the	DET
globalce-157	92	10	device	device	NOUN
globalce-157	92	11	demonstrated	demonstrate	VERB
globalce-157	92	12	an	an	DET
globalce-157	92	13	unexpected	unexpected	ADJ
globalce-157	92	14	behavior	behavior	NOUN
globalce-157	92	15	,	,	PUNCT
globalce-157	92	16	without	without	ADP
globalce-157	92	17	any	any	DET
globalce-157	92	18	further	further	ADJ
globalce-157	92	19	implications	implication	NOUN
globalce-157	92	20	to	to	ADP
globalce-157	92	21	the	the	DET
globalce-157	92	22	patient	patient	NOUN
globalce-157	92	23	or	or	CCONJ
globalce-157	92	24	the	the	DET
globalce-157	92	25	user	user	NOUN
globalce-157	92	26	.	.	PUNCT
globalce-157	93	1	one	one	PRON
globalce-157	93	2	should	should	AUX
globalce-157	93	3	keep	keep	VERB
globalce-157	93	4	in	in	ADP
globalce-157	93	5	mind	mind	NOUN
globalce-157	93	6	that	that	SCONJ
globalce-157	93	7	the	the	DET
globalce-157	93	8	submission	submission	NOUN
globalce-157	93	9	of	of	ADP
globalce-157	93	10	an	an	DET
globalce-157	93	11	mdr	mdr	PROPN
globalce-157	93	12	itself	itself	PRON
globalce-157	93	13	is	be	AUX
globalce-157	93	14	not	not	PART
globalce-157	93	15	evidence	evidence	NOUN
globalce-157	93	16	that	that	SCONJ
globalce-157	93	17	the	the	DET
globalce-157	93	18	device	device	NOUN
globalce-157	93	19	caused	cause	VERB
globalce-157	93	20	or	or	CCONJ
globalce-157	93	21	contributed	contribute	VERB
globalce-157	93	22	to	to	ADP
globalce-157	93	23	the	the	DET
globalce-157	93	24	adverse	adverse	ADJ
globalce-157	93	25	outcome	outcome	NOUN
globalce-157	93	26	or	or	CCONJ
globalce-157	93	27	event	event	NOUN
globalce-157	93	28	.	.	PUNCT
globalce-157	94	1	moreover	moreover	ADV
globalce-157	94	2	,	,	PUNCT
globalce-157	94	3	the	the	DET
globalce-157	94	4	event	event	NOUN
globalce-157	94	5	type	type	NOUN
globalce-157	94	6	field	field	NOUN
globalce-157	94	7	is	be	AUX
globalce-157	94	8	not	not	PART
globalce-157	94	9	available	available	ADJ
globalce-157	94	10	on	on	ADP
globalce-157	94	11	the	the	DET
globalce-157	94	12	form	form	NOUN
globalce-157	94	13	for	for	ADP
globalce-157	94	14	voluntary	voluntary	ADJ
globalce-157	94	15	reporting	reporting	NOUN
globalce-157	94	16	of	of	ADP
globalce-157	94	17	adverse	adverse	ADJ
globalce-157	94	18	events	event	NOUN
globalce-157	94	19	.	.	PUNCT
globalce-157	95	1	remedial	remedial	ADJ
globalce-157	95	2	actions	action	NOUN
globalce-157	95	3	a	a	DET
globalce-157	95	4	remedial	remedial	ADJ
globalce-157	95	5	action	action	NOUN
globalce-157	95	6	(	(	PUNCT
globalce-157	95	7	h7	h7	ADJ
globalce-157	95	8	field	field	NOUN
globalce-157	95	9	on	on	ADP
globalce-157	95	10	the	the	DET
globalce-157	95	11	3500a	3500a	NUM
globalce-157	95	12	form	form	NOUN
globalce-157	95	13	)	)	PUNCT
globalce-157	95	14	corresponds	correspond	VERB
globalce-157	95	15	to	to	ADP
globalce-157	95	16	any	any	DET
globalce-157	95	17	actions	action	NOUN
globalce-157	95	18	outside	outside	ADP
globalce-157	95	19	the	the	DET
globalce-157	95	20	scope	scope	NOUN
globalce-157	95	21	of	of	ADP
globalce-157	95	22	routine	routine	ADJ
globalce-157	95	23	maintenance	maintenance	NOUN
globalce-157	95	24	of	of	ADP
globalce-157	95	25	a	a	DET
globalce-157	95	26	device	device	NOUN
globalce-157	95	27	,	,	PUNCT
globalce-157	95	28	when	when	SCONJ
globalce-157	95	29	necessary	necessary	ADJ
globalce-157	95	30	to	to	PART
globalce-157	95	31	prevent	prevent	VERB
globalce-157	95	32	an	an	DET
globalce-157	95	33	adverse	adverse	ADJ
globalce-157	95	34	event	event	NOUN
globalce-157	95	35	from	from	ADP
globalce-157	95	36	recurring	recur	VERB
globalce-157	95	37	that	that	PRON
globalce-157	95	38	could	could	AUX
globalce-157	95	39	pose	pose	VERB
globalce-157	95	40	safety	safety	NOUN
globalce-157	95	41	issues	issue	NOUN
globalce-157	95	42	.	.	PUNCT
globalce-157	96	1	the	the	DET
globalce-157	96	2	following	follow	VERB
globalce-157	96	3	codes	code	NOUN
globalce-157	96	4	and	and	CCONJ
globalce-157	96	5	their	their	PRON
globalce-157	96	6	interpretations	interpretation	NOUN
globalce-157	96	7	are	be	AUX
globalce-157	96	8	being	be	AUX
globalce-157	96	9	used	use	VERB
globalce-157	96	10	by	by	ADP
globalce-157	96	11	the	the	DET
globalce-157	96	12	maude	maude	PROPN
globalce-157	96	13	database	database	NOUN
globalce-157	96	14	at	at	ADP
globalce-157	96	15	this	this	DET
globalce-157	96	16	point	point	NOUN
globalce-157	96	17	:	:	PUNCT
globalce-157	96	18	rc	rc	PROPN
globalce-157	96	19	=	=	PROPN
globalce-157	96	20	recall	recall	PROPN
globalce-157	96	21	,	,	PUNCT
globalce-157	96	22	rp	rp	NOUN
globalce-157	96	23	=	=	NOUN
globalce-157	96	24	repair	repair	NOUN
globalce-157	96	25	,	,	PUNCT
globalce-157	96	26	rl	rl	CCONJ
globalce-157	96	27	=	=	PUNCT
globalce-157	96	28	replace	replace	NOUN
globalce-157	96	29	,	,	PUNCT
globalce-157	96	30	rb	rb	NOUN
globalce-157	96	31	=	=	SYM
globalce-157	96	32	relabeling	relabeling	NOUN
globalce-157	96	33	,	,	PUNCT
globalce-157	96	34	ot	ot	NOUN
globalce-157	96	35	=	=	ADJ
globalce-157	96	36	other	other	ADJ
globalce-157	96	37	,	,	PUNCT
globalce-157	96	38	no	no	DET
globalce-157	96	39	=	=	NOUN
globalce-157	96	40	notification	notification	NOUN
globalce-157	96	41	,	,	PUNCT
globalce-157	96	42	in	in	ADP
globalce-157	96	43	=	=	NOUN
globalce-157	96	44	inspection	inspection	NOUN
globalce-157	96	45	,	,	PUNCT
globalce-157	96	46	pm	pm	NOUN
globalce-157	96	47	=	=	SYM
globalce-157	96	48	patient	patient	NOUN
globalce-157	96	49	monitoring	monitoring	NOUN
globalce-157	96	50	,	,	PUNCT
globalce-157	96	51	ma	ma	PROPN
globalce-157	96	52	=	=	PROPN
globalce-157	96	53	modification	modification	NOUN
globalce-157	96	54	/	/	SYM
globalce-157	96	55	adjustment	adjustment	NOUN
globalce-157	96	56	,	,	PUNCT
globalce-157	96	57	{	{	PUNCT
globalce-157	96	58	blank}=	blank}=	ADJ
globalce-157	96	59	invalid	invalid	ADJ
globalce-157	96	60	data/	data/	NUM
globalce-157	96	61	nan	nan	PROPN
globalce-157	96	62	.	.	PUNCT
globalce-157	97	1	according	accord	VERB
globalce-157	97	2	to	to	ADP
globalce-157	97	3	21	21	NUM
globalce-157	97	4	cfr	cfr	NOUN
globalce-157	97	5	part	part	NOUN
globalce-157	97	6	7	7	NUM
globalce-157	97	7	,	,	PUNCT
globalce-157	97	8	recall	recall	NOUN
globalce-157	97	9	means	mean	VERB
globalce-157	97	10	a	a	DET
globalce-157	97	11	firm	firm	NOUN
globalce-157	97	12	's	's	PART
globalce-157	97	13	removal	removal	NOUN
globalce-157	97	14	or	or	CCONJ
globalce-157	97	15	correction	correction	NOUN
globalce-157	97	16	of	of	ADP
globalce-157	97	17	a	a	DET
globalce-157	97	18	marketed	market	VERB
globalce-157	97	19	product	product	NOUN
globalce-157	97	20	that	that	PRON
globalce-157	97	21	the	the	DET
globalce-157	97	22	fda	fda	PROPN
globalce-157	97	23	considers	consider	VERB
globalce-157	97	24	to	to	PART
globalce-157	97	25	be	be	AUX
globalce-157	97	26	in	in	ADP
globalce-157	97	27	violation	violation	NOUN
globalce-157	97	28	of	of	ADP
globalce-157	97	29	the	the	DET
globalce-157	97	30	laws	law	NOUN
globalce-157	97	31	it	it	PRON
globalce-157	97	32	administers	administer	VERB
globalce-157	97	33	and	and	CCONJ
globalce-157	97	34	against	against	ADP
globalce-157	97	35	which	which	PRON
globalce-157	97	36	the	the	DET
globalce-157	97	37	agency	agency	NOUN
globalce-157	97	38	would	would	AUX
globalce-157	97	39	initiate	initiate	VERB
globalce-157	97	40	legal	legal	ADJ
globalce-157	97	41	action	action	NOUN
globalce-157	97	42	,	,	PUNCT
globalce-157	97	43	e.g.	e.g.	ADV
globalce-157	97	44	,	,	PUNCT
globalce-157	97	45	seizure.(d	seizure.(d	NOUN
globalce-157	97	46	)	)	PUNCT
globalce-157	97	47	a	a	DET
globalce-157	97	48	recall	recall	NOUN
globalce-157	97	49	can	can	AUX
globalce-157	97	50	be	be	AUX
globalce-157	97	51	initiated	initiate	VERB
globalce-157	97	52	by	by	ADP
globalce-157	97	53	the	the	DET
globalce-157	97	54	manufacturer	manufacturer	NOUN
globalce-157	97	55	,	,	PUNCT
globalce-157	97	56	the	the	DET
globalce-157	97	57	fda	fda	PROPN
globalce-157	97	58	,	,	PUNCT
globalce-157	97	59	or	or	CCONJ
globalce-157	97	60	both	both	PRON
globalce-157	97	61	,	,	PUNCT
globalce-157	97	62	and	and	CCONJ
globalce-157	97	63	may	may	AUX
globalce-157	97	64	be	be	AUX
globalce-157	97	65	required	require	VERB
globalce-157	97	66	when	when	SCONJ
globalce-157	97	67	a	a	DET
globalce-157	97	68	device	device	NOUN
globalce-157	97	69	poses	pose	VERB
globalce-157	97	70	a	a	DET
globalce-157	97	71	significant	significant	ADJ
globalce-157	97	72	risk	risk	NOUN
globalce-157	97	73	of	of	ADP
globalce-157	97	74	harm	harm	NOUN
globalce-157	97	75	to	to	ADP
globalce-157	97	76	patients	patient	NOUN
globalce-157	97	77	or	or	CCONJ
globalce-157	97	78	users	user	NOUN
globalce-157	97	79	.	.	PUNCT
globalce-157	98	1	replacement	replacement	NOUN
globalce-157	98	2	,	,	PUNCT
globalce-157	98	3	on	on	ADP
globalce-157	98	4	the	the	DET
globalce-157	98	5	other	other	ADJ
globalce-157	98	6	hand	hand	NOUN
globalce-157	98	7	,	,	PUNCT
globalce-157	98	8	is	be	AUX
globalce-157	98	9	the	the	DET
globalce-157	98	10	process	process	NOUN
globalce-157	98	11	of	of	ADP
globalce-157	98	12	providing	provide	VERB
globalce-157	98	13	a	a	DET
globalce-157	98	14	new	new	ADJ
globalce-157	98	15	,	,	PUNCT
globalce-157	98	16	corrected	correct	VERB
globalce-157	98	17	or	or	CCONJ
globalce-157	98	18	modified	modify	VERB
globalce-157	98	19	device	device	NOUN
globalce-157	98	20	to	to	PART
globalce-157	98	21	replace	replace	VERB
globalce-157	98	22	a	a	DET
globalce-157	98	23	defective	defective	ADJ
globalce-157	98	24	or	or	CCONJ
globalce-157	98	25	unsafe	unsafe	ADJ
globalce-157	98	26	device	device	NOUN
globalce-157	98	27	that	that	PRON
globalce-157	98	28	has	have	AUX
globalce-157	98	29	already	already	ADV
globalce-157	98	30	been	be	AUX
globalce-157	98	31	distributed	distribute	VERB
globalce-157	98	32	to	to	ADP
globalce-157	98	33	patients	patient	NOUN
globalce-157	98	34	or	or	CCONJ
globalce-157	98	35	healthcare	healthcare	NOUN
globalce-157	98	36	facilities	facility	NOUN
globalce-157	98	37	.	.	PUNCT
globalce-157	99	1	a	a	DET
globalce-157	99	2	replacement	replacement	NOUN
globalce-157	99	3	may	may	AUX
globalce-157	99	4	be	be	AUX
globalce-157	99	5	initiated	initiate	VERB
globalce-157	99	6	by	by	ADP
globalce-157	99	7	the	the	DET
globalce-157	99	8	manufacturer	manufacturer	NOUN
globalce-157	99	9	as	as	ADP
globalce-157	99	10	a	a	DET
globalce-157	99	11	proactive	proactive	ADJ
globalce-157	99	12	measure	measure	NOUN
globalce-157	99	13	to	to	PART
globalce-157	99	14	address	address	VERB
globalce-157	99	15	a	a	DET
globalce-157	99	16	safety	safety	NOUN
globalce-157	99	17	issue	issue	NOUN
globalce-157	99	18	or	or	CCONJ
globalce-157	99	19	may	may	AUX
globalce-157	99	20	be	be	AUX
globalce-157	99	21	required	require	VERB
globalce-157	99	22	by	by	ADP
globalce-157	99	23	the	the	DET
globalce-157	99	24	fda	fda	PROPN
globalce-157	99	25	as	as	ADP
globalce-157	99	26	part	part	NOUN
globalce-157	99	27	of	of	ADP
globalce-157	99	28	a	a	DET
globalce-157	99	29	recall	recall	NOUN
globalce-157	99	30	.	.	PUNCT
globalce-157	100	1	in	in	ADP
globalce-157	100	2	some	some	DET
globalce-157	100	3	cases	case	NOUN
globalce-157	100	4	,	,	PUNCT
globalce-157	100	5	the	the	DET
globalce-157	100	6	manufacturer	manufacturer	NOUN
globalce-157	100	7	may	may	AUX
globalce-157	100	8	offer	offer	VERB
globalce-157	100	9	a	a	DET
globalce-157	100	10	replacement	replacement	NOUN
globalce-157	100	11	device	device	NOUN
globalce-157	100	12	to	to	ADP
globalce-157	100	13	patients	patient	NOUN
globalce-157	100	14	as	as	ADP
globalce-157	100	15	a	a	DET
globalce-157	100	16	voluntary	voluntary	ADJ
globalce-157	100	17	corrective	corrective	ADJ
globalce-157	100	18	action	action	NOUN
globalce-157	100	19	,	,	PUNCT
globalce-157	100	20	even	even	ADV
globalce-157	100	21	if	if	SCONJ
globalce-157	100	22	the	the	DET
globalce-157	100	23	device	device	NOUN
globalce-157	100	24	has	have	AUX
globalce-157	100	25	not	not	PART
globalce-157	100	26	been	be	AUX
globalce-157	100	27	recalled	recall	VERB
globalce-157	100	28	by	by	ADP
globalce-157	100	29	the	the	DET
globalce-157	100	30	fda	fda	PROPN
globalce-157	100	31	.	.	PUNCT
globalce-157	101	1	apart	apart	ADV
globalce-157	101	2	from	from	ADP
globalce-157	101	3	the	the	DET
globalce-157	101	4	removal	removal	NOUN
globalce-157	101	5	of	of	ADP
globalce-157	101	6	the	the	DET
globalce-157	101	7	unsafe	unsafe	ADJ
globalce-157	101	8	device	device	NOUN
globalce-157	101	9	from	from	ADP
globalce-157	101	10	the	the	DET
globalce-157	101	11	market	market	NOUN
globalce-157	101	12	and	and	CCONJ
globalce-157	101	13	the	the	DET
globalce-157	101	14	notification	notification	NOUN
globalce-157	101	15	,	,	PUNCT
globalce-157	101	16	healthcare	healthcare	NOUN
globalce-157	101	17	providers	provider	NOUN
globalce-157	101	18	and	and	CCONJ
globalce-157	101	19	patients	patient	NOUN
globalce-157	101	20	may	may	AUX
globalce-157	101	21	be	be	AUX
globalce-157	101	22	requested	request	VERB
globalce-157	101	23	to	to	PART
globalce-157	101	24	return	return	VERB
globalce-157	101	25	the	the	DET
globalce-157	101	26	device	device	NOUN
globalce-157	101	27	for	for	ADP
globalce-157	101	28	corrective	corrective	ADJ
globalce-157	101	29	action	action	NOUN
globalce-157	101	30	to	to	PART
globalce-157	101	31	address	address	VERB
globalce-157	101	32	the	the	DET
globalce-157	101	33	safety	safety	NOUN
globalce-157	101	34	issue	issue	NOUN
globalce-157	101	35	.	.	PUNCT
globalce-157	102	1	correction	correction	NOUN
globalce-157	102	2	means	mean	VERB
globalce-157	102	3	repair	repair	NOUN
globalce-157	102	4	,	,	PUNCT
globalce-157	102	5	modification	modification	NOUN
globalce-157	102	6	,	,	PUNCT
globalce-157	102	7	adjustment	adjustment	NOUN
globalce-157	102	8	,	,	PUNCT
globalce-157	102	9	relabeling	relabeling	NOUN
globalce-157	102	10	,	,	PUNCT
globalce-157	102	11	destruction	destruction	NOUN
globalce-157	102	12	,	,	PUNCT
globalce-157	102	13	or	or	CCONJ
globalce-157	102	14	inspection	inspection	NOUN
globalce-157	102	15	(	(	PUNCT
globalce-157	102	16	including	include	VERB
globalce-157	102	17	patient	patient	ADJ
globalce-157	102	18	monitoring	monitoring	NOUN
globalce-157	102	19	)	)	PUNCT
globalce-157	102	20	of	of	ADP
globalce-157	102	21	a	a	DET
globalce-157	102	22	product	product	NOUN
globalce-157	102	23	without	without	ADP
globalce-157	102	24	its	its	PRON
globalce-157	102	25	physical	physical	ADJ
globalce-157	102	26	removal	removal	NOUN
globalce-157	102	27	to	to	ADP
globalce-157	102	28	some	some	DET
globalce-157	102	29	other	other	ADJ
globalce-157	102	30	location	location	NOUN
globalce-157	102	31	.	.	PUNCT
globalce-157	103	1	as	as	ADP
globalce-157	103	2	a	a	DET
globalce-157	103	3	result	result	NOUN
globalce-157	103	4	,	,	PUNCT
globalce-157	103	5	an	an	DET
globalce-157	103	6	adverse	adverse	ADJ
globalce-157	103	7	event	event	NOUN
globalce-157	103	8	report	report	NOUN
globalce-157	103	9	may	may	AUX
globalce-157	103	10	be	be	AUX
globalce-157	103	11	associated	associate	VERB
globalce-157	103	12	with	with	ADP
globalce-157	103	13	one	one	NUM
globalce-157	103	14	or	or	CCONJ
globalce-157	103	15	more	more	ADV
globalce-157	103	16	remedial	remedial	ADJ
globalce-157	103	17	action	action	NOUN
globalce-157	103	18	codes	code	NOUN
globalce-157	103	19	,	,	PUNCT
globalce-157	103	20	for	for	ADP
globalce-157	103	21	example	example	NOUN
globalce-157	103	22	rc	rc	PROPN
globalce-157	103	23	,	,	PUNCT
globalce-157	103	24	rp	rp	PROPN
globalce-157	103	25	.	.	PROPN
globalce-157	103	26	report	report	NOUN
globalce-157	103	27	source	source	NOUN
globalce-157	103	28	the	the	DET
globalce-157	103	29	reporting	reporting	NOUN
globalce-157	103	30	source	source	NOUN
globalce-157	103	31	refers	refer	VERB
globalce-157	103	32	to	to	ADP
globalce-157	103	33	the	the	DET
globalce-157	103	34	official	official	ADJ
globalce-157	103	35	submitter	submitter	NOUN
globalce-157	103	36	of	of	ADP
globalce-157	103	37	the	the	DET
globalce-157	103	38	report	report	NOUN
globalce-157	103	39	to	to	ADP
globalce-157	103	40	fda	fda	PROPN
globalce-157	103	41	.	.	PUNCT
globalce-157	104	1	the	the	DET
globalce-157	104	2	available	available	ADJ
globalce-157	104	3	codes	code	NOUN
globalce-157	104	4	are	be	AUX
globalce-157	104	5	p=	p=	ADJ
globalce-157	104	6	voluntary	voluntary	ADJ
globalce-157	104	7	report	report	NOUN
globalce-157	104	8	,	,	PUNCT
globalce-157	104	9	u	u	NOUN
globalce-157	104	10	=	=	PROPN
globalce-157	104	11	user	user	NOUN
globalce-157	104	12	facility	facility	NOUN
globalce-157	104	13	report	report	NOUN
globalce-157	104	14	,	,	PUNCT
globalce-157	104	15	d	d	NOUN
globalce-157	104	16	=	=	SYM
globalce-157	104	17	distributor	distributor	NOUN
globalce-157	104	18	report	report	NOUN
globalce-157	104	19	and	and	CCONJ
globalce-157	104	20	m	m	NOUN
globalce-157	104	21	=	=	ADJ
globalce-157	104	22	manufacturer	manufacturer	NOUN
globalce-157	104	23	report	report	NOUN
globalce-157	104	24	.	.	PUNCT
globalce-157	105	1	the	the	DET
globalce-157	105	2	initial	initial	ADJ
globalce-157	105	3	reporter	reporter	NOUN
globalce-157	105	4	of	of	ADP
globalce-157	105	5	the	the	DET
globalce-157	105	6	event	event	NOUN
globalce-157	105	7	can	can	AUX
globalce-157	105	8	be	be	AUX
globalce-157	105	9	any	any	DET
globalce-157	105	10	person	person	NOUN
globalce-157	105	11	.	.	PUNCT
globalce-157	106	1	for	for	ADP
globalce-157	106	2	example	example	NOUN
globalce-157	106	3	,	,	PUNCT
globalce-157	106	4	an	an	DET
globalce-157	106	5	affected	affected	ADJ
globalce-157	106	6	patient	patient	NOUN
globalce-157	106	7	may	may	AUX
globalce-157	106	8	choose	choose	VERB
globalce-157	106	9	to	to	PART
globalce-157	106	10	submit	submit	VERB
globalce-157	106	11	the	the	DET
globalce-157	106	12	report	report	NOUN
globalce-157	106	13	himself	himself	PRON
globalce-157	106	14	(	(	PUNCT
globalce-157	106	15	using	use	VERB
globalce-157	106	16	the	the	DET
globalce-157	106	17	3500	3500	NUM
globalce-157	106	18	form	form	NOUN
globalce-157	106	19	)	)	PUNCT
globalce-157	106	20	,	,	PUNCT
globalce-157	106	21	which	which	PRON
globalce-157	106	22	will	will	AUX
globalce-157	106	23	then	then	ADV
globalce-157	106	24	be	be	AUX
globalce-157	106	25	classified	classify	VERB
globalce-157	106	26	as	as	ADP
globalce-157	106	27	voluntary	voluntary	ADJ
globalce-157	106	28	report	report	NOUN
globalce-157	106	29	,	,	PUNCT
globalce-157	106	30	or	or	CCONJ
globalce-157	106	31	send	send	VERB
globalce-157	106	32	it	it	PRON
globalce-157	106	33	to	to	ADP
globalce-157	106	34	the	the	DET
globalce-157	106	35	manufacturer	manufacturer	NOUN
globalce-157	106	36	who	who	PRON
globalce-157	106	37	is	be	AUX
globalce-157	106	38	obligated	obligate	VERB
globalce-157	106	39	to	to	PART
globalce-157	106	40	submit	submit	VERB
globalce-157	106	41	it	it	PRON
globalce-157	106	42	(	(	PUNCT
globalce-157	106	43	using	use	VERB
globalce-157	106	44	the	the	DET
globalce-157	106	45	3500a	3500a	NUM
globalce-157	106	46	form	form	NOUN
globalce-157	106	47	)	)	PUNCT
globalce-157	106	48	.	.	PUNCT
globalce-157	107	1	in	in	ADP
globalce-157	107	2	the	the	DET
globalce-157	107	3	latter	latter	ADJ
globalce-157	107	4	case	case	NOUN
globalce-157	107	5	,	,	PUNCT
globalce-157	107	6	the	the	DET
globalce-157	107	7	code	code	NOUN
globalce-157	107	8	m	m	VERB
globalce-157	107	9	will	will	AUX
globalce-157	107	10	be	be	AUX
globalce-157	107	11	used	use	VERB
globalce-157	107	12	.	.	PUNCT
globalce-157	108	1	track	track	NOUN
globalce-157	108	2	is	be	AUX
globalce-157	108	3	also	also	ADV
globalce-157	108	4	kept	keep	VERB
globalce-157	108	5	of	of	ADP
globalce-157	108	6	the	the	DET
globalce-157	108	7	initial	initial	ADJ
globalce-157	108	8	reporter	reporter	NOUN
globalce-157	108	9	.	.	PUNCT
globalce-157	109	1	initial	initial	ADJ
globalce-157	109	2	reporter	reporter	NOUN
globalce-157	109	3	occupation	occupation	NOUN
globalce-157	109	4	regardless	regardless	ADV
globalce-157	109	5	of	of	ADP
globalce-157	109	6	the	the	DET
globalce-157	109	7	formal	formal	ADJ
globalce-157	109	8	submitter	submitter	NOUN
globalce-157	109	9	of	of	ADP
globalce-157	109	10	an	an	DET
globalce-157	109	11	event	event	NOUN
globalce-157	109	12	to	to	ADP
globalce-157	109	13	fda	fda	PROPN
globalce-157	109	14	(	(	PUNCT
globalce-157	109	15	i.e.	i.e.	X
globalce-157	109	16	,	,	PUNCT
globalce-157	109	17	a	a	DET
globalce-157	109	18	user	user	NOUN
globalce-157	109	19	or	or	CCONJ
globalce-157	109	20	a	a	DET
globalce-157	109	21	manufacturer	manufacturer	NOUN
globalce-157	109	22	)	)	PUNCT
globalce-157	109	23	,	,	PUNCT
globalce-157	109	24	the	the	DET
globalce-157	109	25	occupation	occupation	NOUN
globalce-157	109	26	of	of	ADP
globalce-157	109	27	the	the	DET
globalce-157	109	28	initial	initial	ADJ
globalce-157	109	29	reporter	reporter	NOUN
globalce-157	109	30	is	be	AUX
globalce-157	109	31	recorded	record	VERB
globalce-157	109	32	separately	separately	ADV
globalce-157	109	33	(	(	PUNCT
globalce-157	109	34	e3	e3	VERB
globalce-157	109	35	field	field	NOUN
globalce-157	109	36	on	on	ADP
globalce-157	109	37	the	the	DET
globalce-157	109	38	3500a	3500a	NUM
globalce-157	109	39	form	form	NOUN
globalce-157	109	40	)	)	PUNCT
globalce-157	109	41	.	.	PUNCT
globalce-157	110	1	the	the	DET
globalce-157	110	2	classification	classification	NOUN
globalce-157	110	3	codes	code	NOUN
globalce-157	110	4	for	for	ADP
globalce-157	110	5	the	the	DET
globalce-157	110	6	initial	initial	ADJ
globalce-157	110	7	reporter	reporter	NOUN
globalce-157	110	8	occupation	occupation	NOUN
globalce-157	110	9	consist	consist	VERB
globalce-157	110	10	of	of	ADP
globalce-157	110	11	three	three	NUM
globalce-157	110	12	digits	digit	NOUN
globalce-157	110	13	and	and	CCONJ
globalce-157	110	14	can	can	AUX
globalce-157	110	15	be	be	AUX
globalce-157	110	16	found	find	VERB
globalce-157	110	17	on	on	ADP
globalce-157	110	18	the	the	DET
globalce-157	110	19	maude	maude	PROPN
globalce-157	110	20	database	database	NOUN
globalce-157	110	21	site.(e	site.(e	ADP
globalce-157	110	22	)	)	PUNCT
globalce-157	110	23	the	the	DET
globalce-157	110	24	available	available	ADJ
globalce-157	110	25	occupations	occupation	NOUN
globalce-157	110	26	range	range	VERB
globalce-157	110	27	from	from	ADP
globalce-157	110	28	physician	physician	NOUN
globalce-157	110	29	and	and	CCONJ
globalce-157	110	30	patient	patient	ADJ
globalce-157	110	31	to	to	ADP
globalce-157	110	32	biomedical	biomedical	ADJ
globalce-157	110	33	engineer	engineer	NOUN
globalce-157	110	34	or	or	CCONJ
globalce-157	110	35	attorney	attorney	NOUN
globalce-157	110	36	.	.	PUNCT
globalce-157	111	1	device	device	NOUN
globalce-157	111	2	evaluated	evaluate	VERB
globalce-157	111	3	by	by	ADP
globalce-157	111	4	manufacturer	manufacturer	NOUN
globalce-157	111	5	according	accord	VERB
globalce-157	111	6	to	to	ADP
globalce-157	111	7	cfr	cfr	PROPN
globalce-157	111	8	21	21	NUM
globalce-157	111	9	,	,	PUNCT
globalce-157	111	10	803	803	NUM
globalce-157	111	11	,	,	PUNCT
globalce-157	111	12	§	§	NOUN
globalce-157	111	13	50	50	NUM
globalce-157	111	14	,	,	PUNCT
globalce-157	111	15	manufacturers	manufacturer	NOUN
globalce-157	111	16	are	be	AUX
globalce-157	111	17	responsible	responsible	ADJ
globalce-157	111	18	for	for	ADP
globalce-157	111	19	conducting	conduct	VERB
globalce-157	111	20	an	an	DET
globalce-157	111	21	investigation	investigation	NOUN
globalce-157	111	22	of	of	ADP
globalce-157	111	23	each	each	DET
globalce-157	111	24	event	event	NOUN
globalce-157	111	25	and	and	CCONJ
globalce-157	111	26	evaluating	evaluate	VERB
globalce-157	111	27	the	the	DET
globalce-157	111	28	cause	cause	NOUN
globalce-157	111	29	of	of	ADP
globalce-157	111	30	the	the	DET
globalce-157	111	31	event	event	NOUN
globalce-157	111	32	.	.	PUNCT
globalce-157	112	1	in	in	ADP
globalce-157	112	2	case	case	NOUN
globalce-157	112	3	the	the	DET
globalce-157	112	4	device	device	NOUN
globalce-157	112	5	was	be	AUX
globalce-157	112	6	returned	return	VERB
globalce-157	112	7	to	to	ADP
globalce-157	112	8	them	they	PRON
globalce-157	112	9	and	and	CCONJ
globalce-157	112	10	information	information	NOUN
globalce-157	112	11	in	in	ADP
globalce-157	112	12	a	a	DET
globalce-157	112	13	report	report	NOUN
globalce-157	112	14	is	be	AUX
globalce-157	112	15	not	not	PART
globalce-157	112	16	complete	complete	ADJ
globalce-157	112	17	,	,	PUNCT
globalce-157	112	18	they	they	PRON
globalce-157	112	19	must	must	AUX
globalce-157	112	20	provide	provide	VERB
globalce-157	112	21	an	an	DET
globalce-157	112	22	explanation	explanation	NOUN
globalce-157	112	23	on	on	ADP
globalce-157	112	24	why	why	SCONJ
globalce-157	112	25	,	,	PUNCT
globalce-157	112	26	as	as	ADV
globalce-157	112	27	well	well	ADV
globalce-157	112	28	as	as	ADP
globalce-157	112	29	the	the	DET
globalce-157	112	30	steps	step	NOUN
globalce-157	112	31	taken	take	VERB
globalce-157	112	32	to	to	PART
globalce-157	112	33	obtain	obtain	VERB
globalce-157	112	34	it	it	PRON
globalce-157	112	35	.	.	PUNCT
globalce-157	113	1	to	to	ADP
globalce-157	113	2	this	this	DET
globalce-157	113	3	end	end	NOUN
globalce-157	113	4	,	,	PUNCT
globalce-157	113	5	the	the	DET
globalce-157	113	6	“	"	PUNCT
globalce-157	113	7	device	device	NOUN
globalce-157	113	8	evaluated	evaluate	VERB
globalce-157	113	9	by	by	ADP
globalce-157	113	10	manufacturer	manufacturer	NOUN
globalce-157	113	11	”	"	PUNCT
globalce-157	113	12	(	(	PUNCT
globalce-157	113	13	h3	h3	NOUN
globalce-157	113	14	field	field	NOUN
globalce-157	113	15	on	on	ADP
globalce-157	113	16	the	the	DET
globalce-157	113	17	3500a	3500a	NUM
globalce-157	113	18	form	form	NOUN
globalce-157	113	19	)	)	PUNCT
globalce-157	113	20	is	be	AUX
globalce-157	113	21	being	be	AUX
globalce-157	113	22	used	use	VERB
globalce-157	113	23	.	.	PUNCT
globalce-157	114	1	the	the	DET
globalce-157	114	2	acceptable	acceptable	ADJ
globalce-157	114	3	values	value	NOUN
globalce-157	114	4	are	be	AUX
globalce-157	114	5	:	:	PUNCT
globalce-157	114	6	y	y	PROPN
globalce-157	114	7	=	=	PUNCT
globalce-157	114	8	yes	yes	INTJ
globalce-157	114	9	,	,	PUNCT
globalce-157	114	10	n	n	NOUN
globalce-157	114	11	=	=	SYM
globalce-157	114	12	no	no	NOUN
globalce-157	114	13	,	,	PUNCT
globalce-157	114	14	r	r	NOUN
globalce-157	114	15	=	=	NOUN
globalce-157	114	16	device	device	NOUN
globalce-157	114	17	not	not	PART
globalce-157	114	18	returned	return	VERB
globalce-157	114	19	to	to	ADP
globalce-157	114	20	manufacturer	manufacturer	NOUN
globalce-157	114	21	and	and	CCONJ
globalce-157	114	22	{	{	PUNCT
globalce-157	114	23	blank}=	blank}=	NOUN
globalce-157	114	24	no	no	DET
globalce-157	114	25	answer	answer	NOUN
globalce-157	114	26	provided	provide	VERB
globalce-157	114	27	.	.	PUNCT
globalce-157	115	1	these	these	DET
globalce-157	115	2	values	value	NOUN
globalce-157	115	3	are	be	AUX
globalce-157	115	4	mutually	mutually	ADV
globalce-157	115	5	exclusive	exclusive	ADJ
globalce-157	115	6	.	.	PUNCT
globalce-157	116	1	d	d	X
globalce-157	116	2	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7	PROPN
globalce-157	116	3	e	e	NOUN
globalce-157	116	4	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/	VERB
globalce-157	116	5	about	about	ADP
globalce-157	116	6	-	-	PUNCT
globalce-157	116	7	manufacturer	manufacturer	NOUN
globalce-157	116	8	-	-	PUNCT
globalce-157	116	9	and	and	CCONJ
globalce-157	116	10	-	-	PUNCT
globalce-157	116	11	user	user	NOUN
globalce-157	116	12	-	-	PUNCT
globalce-157	116	13	facility	facility	NOUN
globalce-157	116	14	-	-	PUNCT
globalce-157	116	15	device	device	NOUN
globalce-157	116	16	-	-	PUNCT
globalce-157	116	17	experience	experience	NOUN
globalce-157	116	18	-	-	PUNCT
globalce-157	116	19	maude	maude	NOUN
globalce-157	116	20	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7	PROPN
globalce-157	116	21	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
globalce-157	116	22	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
globalce-157	116	23	zisimopoulos	zisimopoulo	NOUN
globalce-157	116	24	,	,	PUNCT
globalce-157	116	25	pallikarakis	pallikarakis	PROPN
globalce-157	116	26	:	:	PUNCT
globalce-157	116	27	an	an	DET
globalce-157	116	28	analysis	analysis	NOUN
globalce-157	116	29	of	of	ADP
globalce-157	116	30	adverse	adverse	ADJ
globalce-157	116	31	event	event	NOUN
globalce-157	116	32	reports	report	NOUN
globalce-157	116	33	in	in	ADP
globalce-157	116	34	fda	fda	PROPN
globalce-157	116	35	’s	’s	PART
globalce-157	116	36	maude	maude	PROPN
globalce-157	116	37	database	database	PROPN
globalce-157	116	38	j	j	PROPN
globalce-157	116	39	global	global	ADJ
globalce-157	116	40	clinical	clinical	ADJ
globalce-157	116	41	engineering	engineering	PROPN
globalce-157	116	42	vol.6	vol.6	PROPN
globalce-157	116	43	issue	issue	NOUN
globalce-157	116	44	1	1	NUM
globalce-157	116	45	:	:	SYM
globalce-157	116	46	2023	2023	NUM
globalce-157	116	47	10	10	NUM
globalce-157	116	48	device	device	NOUN
globalce-157	116	49	age	age	NOUN
globalce-157	116	50	the	the	DET
globalce-157	116	51	associated	associated	ADJ
globalce-157	116	52	device	device	NOUN
globalce-157	116	53	age	age	NOUN
globalce-157	116	54	for	for	ADP
globalce-157	116	55	the	the	DET
globalce-157	116	56	adverse	adverse	ADJ
globalce-157	116	57	events	event	NOUN
globalce-157	116	58	was	be	AUX
globalce-157	116	59	calculated	calculate	VERB
globalce-157	116	60	by	by	ADP
globalce-157	116	61	subtracting	subtract	VERB
globalce-157	116	62	the	the	DET
globalce-157	116	63	year	year	NOUN
globalce-157	116	64	of	of	ADP
globalce-157	116	65	the	the	DET
globalce-157	116	66	device	device	NOUN
globalce-157	116	67	manufacture	manufacture	VERB
globalce-157	116	68	date	date	NOUN
globalce-157	116	69	(	(	PUNCT
globalce-157	116	70	h4	h4	NOUN
globalce-157	116	71	field	field	NOUN
globalce-157	116	72	on	on	ADP
globalce-157	116	73	the	the	DET
globalce-157	116	74	3500a	3500a	NUM
globalce-157	116	75	form	form	NOUN
globalce-157	116	76	)	)	PUNCT
globalce-157	116	77	,	,	PUNCT
globalce-157	116	78	as	as	SCONJ
globalce-157	116	79	filled	fill	VERB
globalce-157	116	80	in	in	ADP
globalce-157	116	81	by	by	ADP
globalce-157	116	82	the	the	DET
globalce-157	116	83	manufacturer	manufacturer	NOUN
globalce-157	116	84	of	of	ADP
globalce-157	116	85	the	the	DET
globalce-157	116	86	device	device	NOUN
globalce-157	116	87	,	,	PUNCT
globalce-157	116	88	from	from	ADP
globalce-157	116	89	the	the	DET
globalce-157	116	90	year	year	NOUN
globalce-157	116	91	in	in	ADP
globalce-157	116	92	which	which	PRON
globalce-157	116	93	the	the	DET
globalce-157	116	94	report	report	NOUN
globalce-157	116	95	was	be	AUX
globalce-157	116	96	submitted	submit	VERB
globalce-157	116	97	to	to	ADP
globalce-157	116	98	the	the	DET
globalce-157	116	99	fda	fda	PROPN
globalce-157	116	100	.	.	PUNCT
globalce-157	117	1	device	device	NOUN
globalce-157	117	2	groups	group	NOUN
globalce-157	117	3	event	event	VERB
globalce-157	117	4	outcomes	outcome	NOUN
globalce-157	117	5	such	such	ADJ
globalce-157	117	6	as	as	ADP
globalce-157	117	7	event	event	NOUN
globalce-157	117	8	type	type	NOUN
globalce-157	117	9	and	and	CCONJ
globalce-157	117	10	remedial	remedial	ADJ
globalce-157	117	11	action	action	NOUN
globalce-157	117	12	were	be	AUX
globalce-157	117	13	analyzed	analyze	VERB
globalce-157	117	14	separately	separately	ADV
globalce-157	117	15	for	for	ADP
globalce-157	117	16	various	various	ADJ
globalce-157	117	17	device	device	NOUN
globalce-157	117	18	groups	group	NOUN
globalce-157	117	19	.	.	PUNCT
globalce-157	118	1	this	this	PRON
globalce-157	118	2	was	be	AUX
globalce-157	118	3	done	do	VERB
globalce-157	118	4	to	to	PART
globalce-157	118	5	investigate	investigate	VERB
globalce-157	118	6	the	the	DET
globalce-157	118	7	differences	difference	NOUN
globalce-157	118	8	an	an	DET
globalce-157	118	9	adverse	adverse	ADJ
globalce-157	118	10	event	event	NOUN
globalce-157	118	11	may	may	AUX
globalce-157	118	12	have	have	VERB
globalce-157	118	13	regarding	regard	VERB
globalce-157	118	14	the	the	DET
globalce-157	118	15	involved	involved	ADJ
globalce-157	118	16	device	device	NOUN
globalce-157	118	17	.	.	PUNCT
globalce-157	119	1	the	the	DET
globalce-157	119	2	md	md	PROPN
globalce-157	119	3	groups	group	NOUN
globalce-157	119	4	chosen	choose	VERB
globalce-157	119	5	were	be	AUX
globalce-157	119	6	ones	one	NOUN
globalce-157	119	7	with	with	ADP
globalce-157	119	8	a	a	DET
globalce-157	119	9	notable	notable	ADJ
globalce-157	119	10	percentage	percentage	NOUN
globalce-157	119	11	of	of	ADP
globalce-157	119	12	each	each	DET
globalce-157	119	13	year	year	NOUN
globalce-157	119	14	’s	’s	PART
globalce-157	119	15	total	total	ADJ
globalce-157	119	16	reports	report	NOUN
globalce-157	119	17	and	and	CCONJ
globalce-157	119	18	are	be	AUX
globalce-157	119	19	presented	present	VERB
globalce-157	119	20	in	in	ADP
globalce-157	119	21	table	table	NOUN
globalce-157	119	22	1	1	NUM
globalce-157	119	23	.	.	PUNCT
globalce-157	119	24	results	result	VERB
globalce-157	119	25	number	number	NOUN
globalce-157	119	26	of	of	ADP
globalce-157	119	27	reports	report	NOUN
globalce-157	119	28	the	the	DET
globalce-157	119	29	histogram	histogram	NOUN
globalce-157	119	30	of	of	ADP
globalce-157	119	31	the	the	DET
globalce-157	119	32	annual	annual	ADJ
globalce-157	119	33	number	number	NOUN
globalce-157	119	34	of	of	ADP
globalce-157	119	35	submitted	submit	VERB
globalce-157	119	36	reports	report	NOUN
globalce-157	119	37	to	to	ADP
globalce-157	119	38	fda	fda	PROPN
globalce-157	119	39	from	from	ADP
globalce-157	119	40	1997	1997	NUM
globalce-157	119	41	to	to	ADP
globalce-157	119	42	2022	2022	NUM
globalce-157	119	43	is	be	AUX
globalce-157	119	44	presented	present	VERB
globalce-157	119	45	in	in	ADP
globalce-157	119	46	figure	figure	NOUN
globalce-157	119	47	1	1	NUM
globalce-157	119	48	.	.	PUNCT
globalce-157	119	49	about	about	ADV
globalce-157	119	50	15	15	NUM
globalce-157	119	51	million	million	NUM
globalce-157	119	52	reports	report	NOUN
globalce-157	119	53	have	have	AUX
globalce-157	119	54	been	be	AUX
globalce-157	119	55	submitted	submit	VERB
globalce-157	119	56	to	to	ADP
globalce-157	119	57	maude	maude	NOUN
globalce-157	119	58	until	until	ADP
globalce-157	119	59	the	the	DET
globalce-157	119	60	end	end	NOUN
globalce-157	119	61	of	of	ADP
globalce-157	119	62	2022	2022	NUM
globalce-157	119	63	and	and	CCONJ
globalce-157	119	64	over	over	ADP
globalce-157	119	65	2.5	2.5	NUM
globalce-157	119	66	million	million	NUM
globalce-157	119	67	of	of	ADP
globalce-157	119	68	them	they	PRON
globalce-157	119	69	occurred	occur	VERB
globalce-157	119	70	during	during	ADP
globalce-157	119	71	the	the	DET
globalce-157	119	72	last	last	ADJ
globalce-157	119	73	year	year	NOUN
globalce-157	119	74	.	.	PUNCT
globalce-157	120	1	a	a	DET
globalce-157	120	2	big	big	ADJ
globalce-157	120	3	increase	increase	NOUN
globalce-157	120	4	in	in	ADP
globalce-157	120	5	the	the	DET
globalce-157	120	6	number	number	NOUN
globalce-157	120	7	of	of	ADP
globalce-157	120	8	reports	report	NOUN
globalce-157	120	9	can	can	AUX
globalce-157	120	10	be	be	AUX
globalce-157	120	11	observed	observe	VERB
globalce-157	120	12	over	over	ADP
globalce-157	120	13	the	the	DET
globalce-157	120	14	last	last	ADJ
globalce-157	120	15	few	few	ADJ
globalce-157	120	16	years	year	NOUN
globalce-157	120	17	.	.	PUNCT
globalce-157	121	1	event	event	NOUN
globalce-157	121	2	types	type	NOUN
globalce-157	121	3	table	table	VERB
globalce-157	121	4	2	2	NUM
globalce-157	121	5	presents	present	VERB
globalce-157	121	6	the	the	DET
globalce-157	121	7	distribution	distribution	NOUN
globalce-157	121	8	of	of	ADP
globalce-157	121	9	event	event	NOUN
globalce-157	121	10	types	type	NOUN
globalce-157	121	11	for	for	ADP
globalce-157	121	12	6	6	NUM
globalce-157	121	13	different	different	ADJ
globalce-157	121	14	examples	example	NOUN
globalce-157	121	15	of	of	ADP
globalce-157	121	16	prominent	prominent	ADJ
globalce-157	121	17	md	md	PROPN
globalce-157	121	18	groups	group	NOUN
globalce-157	121	19	,	,	PUNCT
globalce-157	121	20	as	as	ADV
globalce-157	121	21	well	well	ADV
globalce-157	121	22	as	as	ADP
globalce-157	121	23	all	all	DET
globalce-157	121	24	the	the	DET
globalce-157	121	25	average	average	ADJ
globalce-157	121	26	values	value	NOUN
globalce-157	121	27	for	for	ADP
globalce-157	121	28	all	all	DET
globalce-157	121	29	available	available	ADJ
globalce-157	121	30	fda	fda	PROPN
globalce-157	121	31	device	device	NOUN
globalce-157	121	32	groups	group	NOUN
globalce-157	121	33	that	that	PRON
globalce-157	121	34	exist	exist	VERB
globalce-157	121	35	in	in	ADP
globalce-157	121	36	maude	maude	PROPN
globalce-157	121	37	.	.	PUNCT
globalce-157	122	1	from	from	ADP
globalce-157	122	2	the	the	DET
globalce-157	122	3	grand	grand	ADJ
globalce-157	122	4	total	total	NOUN
globalce-157	122	5	of	of	ADP
globalce-157	122	6	the	the	DET
globalce-157	122	7	reports	report	NOUN
globalce-157	122	8	in	in	ADP
globalce-157	122	9	table	table	NOUN
globalce-157	122	10	2	2	NUM
globalce-157	122	11	,	,	PUNCT
globalce-157	122	12	we	we	PRON
globalce-157	122	13	can	can	AUX
globalce-157	122	14	see	see	VERB
globalce-157	122	15	that	that	SCONJ
globalce-157	122	16	most	most	ADJ
globalce-157	122	17	of	of	ADP
globalce-157	122	18	the	the	DET
globalce-157	122	19	events	event	NOUN
globalce-157	122	20	result	result	VERB
globalce-157	122	21	in	in	ADP
globalce-157	122	22	simple	simple	ADJ
globalce-157	122	23	device	device	NOUN
globalce-157	122	24	malfunction	malfunction	NOUN
globalce-157	122	25	,	,	PUNCT
globalce-157	122	26	without	without	ADP
globalce-157	122	27	further	further	ADJ
globalce-157	122	28	implications	implication	NOUN
globalce-157	122	29	to	to	ADP
globalce-157	122	30	the	the	DET
globalce-157	122	31	patient	patient	NOUN
globalce-157	122	32	(	(	PUNCT
globalce-157	122	33	63.5	63.5	NUM
globalce-157	122	34	%	%	NOUN
globalce-157	122	35	)	)	PUNCT
globalce-157	122	36	.	.	PUNCT
globalce-157	123	1	about	about	ADV
globalce-157	123	2	1	1	NUM
globalce-157	123	3	%	%	NOUN
globalce-157	123	4	of	of	ADP
globalce-157	123	5	the	the	DET
globalce-157	123	6	total	total	ADJ
globalce-157	123	7	reported	report	VERB
globalce-157	123	8	events	event	NOUN
globalce-157	123	9	is	be	AUX
globalce-157	123	10	associated	associate	VERB
globalce-157	123	11	with	with	ADP
globalce-157	123	12	patient	patient	ADJ
globalce-157	123	13	death	death	NOUN
globalce-157	123	14	.	.	PUNCT
globalce-157	124	1	table	table	NOUN
globalce-157	124	2	2	2	NUM
globalce-157	124	3	.	.	PUNCT
globalce-157	124	4	event	event	NOUN
globalce-157	124	5	type	type	NOUN
globalce-157	124	6	distribution	distribution	NOUN
globalce-157	124	7	for	for	ADP
globalce-157	124	8	various	various	ADJ
globalce-157	124	9	md	md	PROPN
globalce-157	124	10	groups	group	NOUN
globalce-157	124	11	event	event	PROPN
globalce-157	124	12	type	type	NOUN
globalce-157	124	13	malfunction	malfunction	PROPN
globalce-157	124	14	injury	injury	PROPN
globalce-157	124	15	death	death	NOUN
globalce-157	124	16	other	other	ADJ
globalce-157	124	17	n	n	CCONJ
globalce-157	124	18	/	/	SYM
globalce-157	124	19	a	a	DET
globalce-157	124	20	glucose	glucose	NOUN
globalce-157	124	21	monitors	monitor	NOUN
globalce-157	125	1	[	[	X
globalce-157	125	2	'	'	X
globalce-157	125	3	mds	mds	NOUN
globalce-157	125	4	'	'	PUNCT
globalce-157	125	5	,	,	PUNCT
globalce-157	125	6	'	'	PUNCT
globalce-157	125	7	oyc	oyc	PROPN
globalce-157	125	8	'	'	PUNCT
globalce-157	125	9	,	,	PUNCT
globalce-157	125	10	'	'	PUNCT
globalce-157	125	11	pqf	pqf	NOUN
globalce-157	125	12	'	'	PUNCT
globalce-157	125	13	]	]	PUNCT
globalce-157	125	14	89.1	89.1	NUM
globalce-157	125	15	10.7	10.7	NUM
globalce-157	125	16	0.2	0.2	NUM
globalce-157	125	17	≈	≈	PROPN
globalce-157	125	18	0.0	0.0	NUM
globalce-157	125	19	glucose	glucose	NOUN
globalce-157	125	20	test	test	NOUN
globalce-157	125	21	[	[	X
globalce-157	125	22	'	'	PUNCT
globalce-157	125	23	cfr	cfr	NOUN
globalce-157	125	24	'	'	PUNCT
globalce-157	125	25	,	,	PUNCT
globalce-157	125	26	'	'	PUNCT
globalce-157	125	27	lfr	lfr	PROPN
globalce-157	125	28	'	'	PUNCT
globalce-157	125	29	,	,	PUNCT
globalce-157	125	30	'	'	PUNCT
globalce-157	125	31	nbw	nbw	ADJ
globalce-157	125	32	'	'	PUNCT
globalce-157	125	33	]	]	X
globalce-157	125	34	90.2	90.2	NUM
globalce-157	125	35	9.0	9.0	NUM
globalce-157	125	36	≈	≈	PROPN
globalce-157	125	37	0.0	0.0	NUM
globalce-157	125	38	0.8	0.8	NUM
globalce-157	125	39	pump	pump	NOUN
globalce-157	125	40	,	,	PUNCT
globalce-157	125	41	infusion	infusion	NOUN
globalce-157	125	42	98.3	98.3	NUM
globalce-157	125	43	1.4	1.4	NUM
globalce-157	126	1	≈	≈	PROPN
globalce-157	126	2	0.1	0.1	NUM
globalce-157	127	1	≈	≈	PROPN
globalce-157	127	2	0.2	0.2	NUM
globalce-157	127	3	implantable	implantable	ADJ
globalce-157	127	4	cardioverter	cardioverter	NOUN
globalce-157	127	5	defibrillator	defibrillator	NOUN
globalce-157	127	6	(	(	PUNCT
globalce-157	127	7	non	non	ADJ
globalce-157	127	8	-	-	ADJ
globalce-157	127	9	crt	crt	ADJ
globalce-157	127	10	)	)	PUNCT
globalce-157	127	11	36.3	36.3	NUM
globalce-157	127	12	60.0	60.0	NUM
globalce-157	127	13	3.2	3.2	NUM
globalce-157	127	14	≈	≈	PROPN
globalce-157	127	15	0.5	0.5	NUM
globalce-157	127	16	prosthesis	prosthesis	NOUN
globalce-157	127	17	,	,	PUNCT
globalce-157	127	18	hip	hip	NOUN
globalce-157	127	19	,	,	PUNCT
globalce-157	127	20	semiconstrained	semiconstrained	ADJ
globalce-157	127	21	(	(	PUNCT
globalce-157	127	22	metal	metal	NOUN
globalce-157	127	23	uncemented	uncemented	ADJ
globalce-157	127	24	acetabular	acetabular	ADJ
globalce-157	127	25	component	component	NOUN
globalce-157	127	26	)	)	PUNCT
globalce-157	127	27	2.7	2.7	NUM
globalce-157	127	28	95.0	95.0	NUM
globalce-157	127	29	0.3	0.3	NUM
globalce-157	127	30	≈	≈	PROPN
globalce-157	127	31	0.0	0.0	NUM
globalce-157	127	32	implant	implant	ADJ
globalce-157	127	33	,	,	PUNCT
globalce-157	127	34	endosseous	endosseous	ADJ
globalce-157	127	35	,	,	PUNCT
globalce-157	127	36	root	root	NOUN
globalce-157	127	37	-	-	PUNCT
globalce-157	127	38	form	form	NOUN
globalce-157	127	39	1.6	1.6	NUM
globalce-157	127	40	98.4	98.4	NUM
globalce-157	128	1	≈	≈	PROPN
globalce-157	128	2	0.0	0.0	NUM
globalce-157	128	3	≈	≈	PROPN
globalce-157	128	4	0.0	0.0	NUM
globalce-157	128	5	average	average	NOUN
globalce-157	128	6	for	for	ADP
globalce-157	128	7	all	all	DET
globalce-157	128	8	device	device	NOUN
globalce-157	128	9	groups	group	NOUN
globalce-157	128	10	63.5	63.5	NUM
globalce-157	128	11	34.3	34.3	NUM
globalce-157	128	12	1.2	1.2	NUM
globalce-157	128	13	1.0	1.0	NUM
globalce-157	128	14	the	the	DET
globalce-157	128	15	average	average	ADJ
globalce-157	128	16	numbers	number	NOUN
globalce-157	128	17	derived	derive	VERB
globalce-157	128	18	from	from	ADP
globalce-157	128	19	all	all	DET
globalce-157	128	20	the	the	DET
globalce-157	128	21	available	available	ADJ
globalce-157	128	22	device	device	NOUN
globalce-157	128	23	types	type	NOUN
globalce-157	128	24	can	can	AUX
globalce-157	128	25	vary	vary	VERB
globalce-157	128	26	significantly	significantly	ADV
globalce-157	128	27	across	across	ADP
globalce-157	128	28	different	different	ADJ
globalce-157	128	29	device	device	NOUN
globalce-157	128	30	groups	group	NOUN
globalce-157	128	31	.	.	PUNCT
globalce-157	129	1	as	as	SCONJ
globalce-157	129	2	observed	observe	VERB
globalce-157	129	3	in	in	ADP
globalce-157	129	4	the	the	DET
globalce-157	129	5	trend	trend	NOUN
globalce-157	129	6	(	(	PUNCT
globalce-157	129	7	figure	figure	NOUN
globalce-157	129	8	3	3	NUM
globalce-157	129	9	)	)	PUNCT
globalce-157	129	10	,	,	PUNCT
globalce-157	129	11	there	there	PRON
globalce-157	129	12	is	be	VERB
globalce-157	129	13	a	a	DET
globalce-157	129	14	steady	steady	ADJ
globalce-157	129	15	decline	decline	NOUN
globalce-157	129	16	in	in	ADP
globalce-157	129	17	the	the	DET
globalce-157	129	18	ratio	ratio	NOUN
globalce-157	129	19	of	of	ADP
globalce-157	129	20	adverse	adverse	ADJ
globalce-157	129	21	events	event	NOUN
globalce-157	129	22	that	that	PRON
globalce-157	129	23	result	result	VERB
globalce-157	129	24	in	in	ADP
globalce-157	129	25	deaths	death	NOUN
globalce-157	129	26	,	,	PUNCT
globalce-157	129	27	from	from	ADP
globalce-157	129	28	2.5	2.5	NUM
globalce-157	129	29	%	%	NOUN
globalce-157	129	30	up	up	ADV
globalce-157	129	31	until	until	ADP
globalce-157	129	32	1997	1997	NUM
globalce-157	129	33	to	to	ADP
globalce-157	129	34	0.3	0.3	NUM
globalce-157	129	35	%	%	NOUN
globalce-157	129	36	in	in	ADP
globalce-157	129	37	2022	2022	NUM
globalce-157	129	38	(	(	PUNCT
globalce-157	129	39	r2	r2	NOUN
globalce-157	129	40	=	=	NOUN
globalce-157	129	41	0.66	0.66	NUM
globalce-157	129	42	)	)	PUNCT
globalce-157	129	43	.	.	PUNCT
globalce-157	130	1	similarly	similarly	ADV
globalce-157	130	2	,	,	PUNCT
globalce-157	130	3	events	event	NOUN
globalce-157	130	4	with	with	ADP
globalce-157	130	5	outcome	outcome	NOUN
globalce-157	130	6	categorized	categorize	VERB
globalce-157	130	7	as	as	ADP
globalce-157	130	8	“	"	PUNCT
globalce-157	130	9	other	other	ADJ
globalce-157	130	10	”	"	PUNCT
globalce-157	130	11	or	or	CCONJ
globalce-157	130	12	without	without	ADP
globalce-157	130	13	applicable	applicable	ADJ
globalce-157	130	14	information	information	NOUN
globalce-157	130	15	(	(	PUNCT
globalce-157	130	16	n	n	CCONJ
globalce-157	130	17	/	/	SYM
globalce-157	130	18	a	a	PRON
globalce-157	130	19	)	)	PUNCT
globalce-157	130	20	decreased	decrease	VERB
globalce-157	130	21	from	from	ADP
globalce-157	130	22	7.5	7.5	NUM
globalce-157	130	23	%	%	NOUN
globalce-157	130	24	in	in	ADP
globalce-157	130	25	1997	1997	NUM
globalce-157	130	26	to	to	ADP
globalce-157	130	27	almost	almost	ADV
globalce-157	130	28	0	0	NUM
globalce-157	130	29	%	%	NOUN
globalce-157	130	30	in	in	ADP
globalce-157	130	31	2022	2022	NUM
globalce-157	130	32	(	(	PUNCT
globalce-157	130	33	r2	r2	NOUN
globalce-157	130	34	=	=	SYM
globalce-157	130	35	0.85	0.85	NUM
globalce-157	130	36	)	)	PUNCT
globalce-157	130	37	,	,	PUNCT
globalce-157	130	38	showing	show	VERB
globalce-157	130	39	table	table	NOUN
globalce-157	130	40	1	1	NUM
globalce-157	130	41	.	.	PUNCT
globalce-157	130	42	medical	medical	ADJ
globalce-157	130	43	device	device	NOUN
globalce-157	130	44	groups	group	NOUN
globalce-157	130	45	with	with	ADP
globalce-157	130	46	frequently	frequently	ADV
globalce-157	130	47	presented	present	VERB
globalce-157	130	48	adverse	adverse	ADJ
globalce-157	130	49	events	event	NOUN
globalce-157	130	50	fda	fda	PROPN
globalce-157	130	51	group	group	PROPN
globalce-157	130	52	code	code	PROPN
globalce-157	130	53	group	group	PROPN
globalce-157	130	54	name	name	PROPN
globalce-157	130	55	cfr	cfr	PROPN
globalce-157	130	56	hexokinase	hexokinase	NOUN
globalce-157	130	57	,	,	PUNCT
globalce-157	130	58	glucose	glucose	NOUN
globalce-157	130	59	lfr	lfr	PROPN
globalce-157	130	60	glucose	glucose	NOUN
globalce-157	130	61	dehydrogenase	dehydrogenase	NOUN
globalce-157	130	62	,	,	PUNCT
globalce-157	130	63	glucose	glucose	NOUN
globalce-157	130	64	nbw	nbw	ADJ
globalce-157	130	65	system	system	NOUN
globalce-157	130	66	,	,	PUNCT
globalce-157	130	67	test	test	NOUN
globalce-157	130	68	,	,	PUNCT
globalce-157	130	69	blood	blood	NOUN
globalce-157	130	70	glucose	glucose	NOUN
globalce-157	130	71	,	,	PUNCT
globalce-157	130	72	over	over	ADP
globalce-157	130	73	the	the	DET
globalce-157	130	74	counter	counter	PROPN
globalce-157	130	75	mds	mds	PROPN
globalce-157	130	76	sensor	sensor	PROPN
globalce-157	130	77	,	,	PUNCT
globalce-157	130	78	glucose	glucose	NOUN
globalce-157	130	79	,	,	PUNCT
globalce-157	130	80	invasive	invasive	ADJ
globalce-157	130	81	oyc	oyc	NOUN
globalce-157	130	82	pump	pump	NOUN
globalce-157	130	83	,	,	PUNCT
globalce-157	130	84	infusion	infusion	NOUN
globalce-157	130	85	,	,	PUNCT
globalce-157	130	86	insulin	insulin	NOUN
globalce-157	130	87	,	,	PUNCT
globalce-157	130	88	to	to	PART
globalce-157	130	89	be	be	AUX
globalce-157	130	90	used	use	VERB
globalce-157	130	91	with	with	ADP
globalce-157	130	92	invasive	invasive	ADJ
globalce-157	130	93	glucose	glucose	NOUN
globalce-157	130	94	sensor	sensor	NOUN
globalce-157	130	95	pqf	pqf	PROPN
globalce-157	130	96	sensor	sensor	NOUN
globalce-157	130	97	,	,	PUNCT
globalce-157	130	98	glucose	glucose	NOUN
globalce-157	130	99	,	,	PUNCT
globalce-157	130	100	invasive	invasive	ADJ
globalce-157	130	101	,	,	PUNCT
globalce-157	130	102	non	non	ADJ
globalce-157	130	103	-	-	ADJ
globalce-157	130	104	adjunctive	adjunctive	ADJ
globalce-157	130	105	lws	lws	PROPN
globalce-157	130	106	implantable	implantable	ADJ
globalce-157	130	107	cardioverter	cardioverter	NOUN
globalce-157	130	108	defibrillator	defibrillator	NOUN
globalce-157	130	109	(	(	PUNCT
globalce-157	130	110	non	non	ADJ
globalce-157	130	111	-	-	ADJ
globalce-157	130	112	crt	crt	ADJ
globalce-157	130	113	)	)	PUNCT
globalce-157	130	114	dze	dze	PROPN
globalce-157	130	115	implant	implant	ADJ
globalce-157	130	116	,	,	PUNCT
globalce-157	130	117	endosseous	endosseous	ADJ
globalce-157	130	118	,	,	PUNCT
globalce-157	130	119	root	root	NOUN
globalce-157	130	120	-	-	PUNCT
globalce-157	130	121	form	form	NOUN
globalce-157	130	122	frn	frn	PROPN
globalce-157	130	123	pump	pump	NOUN
globalce-157	130	124	,	,	PUNCT
globalce-157	130	125	infusion	infusion	NOUN
globalce-157	130	126	kwa	kwa	PROPN
globalce-157	130	127	prosthesis	prosthesis	PROPN
globalce-157	130	128	,	,	PUNCT
globalce-157	130	129	hip	hip	NOUN
globalce-157	130	130	,	,	PUNCT
globalce-157	130	131	semi	semi	ADJ
globalce-157	130	132	-	-	ADJ
globalce-157	130	133	constrained	constrained	ADJ
globalce-157	130	134	(	(	PUNCT
globalce-157	130	135	metal	metal	NOUN
globalce-157	130	136	uncemented	uncemented	ADJ
globalce-157	130	137	acetabular	acetabular	ADJ
globalce-157	130	138	component	component	NOUN
globalce-157	130	139	)	)	PUNCT
globalce-157	130	140	11	11	NUM
globalce-157	130	141	j	j	PROPN
globalce-157	130	142	global	global	ADJ
globalce-157	130	143	clinical	clinical	ADJ
globalce-157	130	144	engineering	engineering	PROPN
globalce-157	130	145	vol.6	vol.6	PROPN
globalce-157	130	146	issue	issue	NOUN
globalce-157	130	147	1	1	NUM
globalce-157	130	148	:	:	SYM
globalce-157	130	149	2023	2023	NUM
globalce-157	130	150	zisimopoulos	zisimopoulo	NOUN
globalce-157	130	151	,	,	PUNCT
globalce-157	130	152	pallikarakis	pallikarakis	PROPN
globalce-157	130	153	:	:	PUNCT
globalce-157	130	154	an	an	DET
globalce-157	130	155	analysis	analysis	NOUN
globalce-157	130	156	of	of	ADP
globalce-157	130	157	adverse	adverse	ADJ
globalce-157	130	158	event	event	NOUN
globalce-157	130	159	reports	report	NOUN
globalce-157	130	160	in	in	ADP
globalce-157	130	161	fda	fda	PROPN
globalce-157	130	162	’s	’s	PART
globalce-157	130	163	maude	maude	PROPN
globalce-157	130	164	database	database	PROPN
globalce-157	130	165	the	the	DET
globalce-157	130	166	increased	increase	VERB
globalce-157	130	167	completeness	completeness	NOUN
globalce-157	130	168	of	of	ADP
globalce-157	130	169	the	the	DET
globalce-157	130	170	information	information	NOUN
globalce-157	130	171	provided	provide	VERB
globalce-157	130	172	to	to	ADP
globalce-157	130	173	the	the	DET
globalce-157	130	174	fda	fda	PROPN
globalce-157	130	175	over	over	ADP
globalce-157	130	176	the	the	DET
globalce-157	130	177	years	year	NOUN
globalce-157	130	178	.	.	PUNCT
globalce-157	131	1	subsequently	subsequently	ADV
globalce-157	131	2	,	,	PUNCT
globalce-157	131	3	more	more	ADJ
globalce-157	131	4	incidents	incident	NOUN
globalce-157	131	5	are	be	AUX
globalce-157	131	6	manifested	manifest	VERB
globalce-157	131	7	as	as	ADP
globalce-157	131	8	device	device	NOUN
globalce-157	131	9	malfunctions	malfunction	NOUN
globalce-157	131	10	,	,	PUNCT
globalce-157	131	11	with	with	ADP
globalce-157	131	12	73	73	NUM
globalce-157	131	13	%	%	NOUN
globalce-157	131	14	reported	report	VERB
globalce-157	131	15	as	as	ADP
globalce-157	131	16	such	such	ADJ
globalce-157	131	17	in	in	ADP
globalce-157	131	18	2022	2022	NUM
globalce-157	131	19	,	,	PUNCT
globalce-157	131	20	compared	compare	VERB
globalce-157	131	21	to	to	ADP
globalce-157	131	22	only	only	ADV
globalce-157	131	23	40	40	NUM
globalce-157	131	24	%	%	NOUN
globalce-157	131	25	up	up	ADP
globalce-157	131	26	to	to	ADP
globalce-157	131	27	1997	1997	NUM
globalce-157	131	28	(	(	PUNCT
globalce-157	131	29	r2	r2	PROPN
globalce-157	131	30	=	=	PUNCT
globalce-157	131	31	38	38	NUM
globalce-157	131	32	%	%	NOUN
globalce-157	131	33	)	)	PUNCT
globalce-157	131	34	.	.	PUNCT
globalce-157	132	1	although	although	SCONJ
globalce-157	132	2	injury	injury	NOUN
globalce-157	132	3	reports	report	NOUN
globalce-157	132	4	dropped	drop	VERB
globalce-157	132	5	from	from	ADP
globalce-157	132	6	49.2	49.2	NUM
globalce-157	132	7	%	%	NOUN
globalce-157	132	8	in	in	ADP
globalce-157	132	9	the	the	DET
globalce-157	132	10	period	period	NOUN
globalce-157	132	11	1991	1991	NUM
globalce-157	132	12	1997	1997	NUM
globalce-157	132	13	to	to	ADP
globalce-157	132	14	26.6	26.6	NUM
globalce-157	132	15	%	%	NOUN
globalce-157	132	16	in	in	ADP
globalce-157	132	17	2022	2022	NUM
globalce-157	132	18	,	,	PUNCT
globalce-157	132	19	their	their	PRON
globalce-157	132	20	fluctuations	fluctuation	NOUN
globalce-157	132	21	seem	seem	VERB
globalce-157	132	22	to	to	PART
globalce-157	132	23	be	be	AUX
globalce-157	132	24	independent	independent	ADJ
globalce-157	132	25	of	of	ADP
globalce-157	132	26	the	the	DET
globalce-157	132	27	time	time	NOUN
globalce-157	132	28	(	(	PUNCT
globalce-157	132	29	r2	r2	PROPN
globalce-157	132	30	≈	≈	PROPN
globalce-157	132	31	0	0	NUM
globalce-157	132	32	)	)	PUNCT
globalce-157	132	33	.	.	PUNCT
globalce-157	133	1	according	accord	VERB
globalce-157	133	2	to	to	ADP
globalce-157	133	3	table	table	NOUN
globalce-157	133	4	2	2	NUM
globalce-157	133	5	,	,	PUNCT
globalce-157	133	6	more	more	ADJ
globalce-157	133	7	than	than	ADP
globalce-157	133	8	90	90	NUM
globalce-157	133	9	%	%	NOUN
globalce-157	133	10	of	of	ADP
globalce-157	133	11	events	event	NOUN
globalce-157	133	12	related	relate	VERB
globalce-157	133	13	to	to	ADP
globalce-157	133	14	glucose	glucose	NOUN
globalce-157	133	15	test	test	NOUN
globalce-157	133	16	groups	group	NOUN
globalce-157	133	17	have	have	AUX
globalce-157	133	18	been	be	AUX
globalce-157	133	19	about	about	ADP
globalce-157	133	20	device	device	NOUN
globalce-157	133	21	malfunctions	malfunction	NOUN
globalce-157	133	22	,	,	PUNCT
globalce-157	133	23	with	with	ADP
globalce-157	133	24	the	the	DET
globalce-157	133	25	rest	rest	NOUN
globalce-157	133	26	(	(	PUNCT
globalce-157	133	27	about	about	ADV
globalce-157	133	28	10	10	NUM
globalce-157	133	29	%	%	NOUN
globalce-157	133	30	)	)	PUNCT
globalce-157	133	31	being	be	AUX
globalce-157	133	32	associated	associate	VERB
globalce-157	133	33	with	with	ADP
globalce-157	133	34	injuries	injury	NOUN
globalce-157	133	35	.	.	PUNCT
globalce-157	134	1	in	in	ADP
globalce-157	134	2	contrast	contrast	NOUN
globalce-157	134	3	,	,	PUNCT
globalce-157	134	4	about	about	ADV
globalce-157	134	5	95	95	NUM
globalce-157	134	6	%	%	NOUN
globalce-157	134	7	of	of	ADP
globalce-157	134	8	the	the	DET
globalce-157	134	9	reported	report	VERB
globalce-157	134	10	incidents	incident	NOUN
globalce-157	134	11	of	of	ADP
globalce-157	134	12	metal	metal	NOUN
globalce-157	134	13	uncemented	uncemented	ADJ
globalce-157	134	14	acetabular	acetabular	ADJ
globalce-157	134	15	component	component	NOUN
globalce-157	134	16	hip	hip	NOUN
globalce-157	134	17	prostheses	prosthesis	NOUN
globalce-157	134	18	(	(	PUNCT
globalce-157	134	19	kwa	kwa	PROPN
globalce-157	134	20	)	)	PUNCT
globalce-157	134	21	resulted	result	VERB
globalce-157	134	22	in	in	ADP
globalce-157	134	23	patient	patient	ADJ
globalce-157	134	24	injury	injury	NOUN
globalce-157	134	25	.	.	PUNCT
globalce-157	135	1	similarly	similarly	ADV
globalce-157	135	2	with	with	ADP
globalce-157	135	3	implantable	implantable	ADJ
globalce-157	135	4	defibrillators	defibrillator	NOUN
globalce-157	135	5	,	,	PUNCT
globalce-157	135	6	the	the	DET
globalce-157	135	7	majority	majority	NOUN
globalce-157	135	8	of	of	ADP
globalce-157	135	9	dental	dental	ADJ
globalce-157	135	10	implant	implant	ADJ
globalce-157	135	11	event	event	NOUN
globalce-157	135	12	types	type	NOUN
globalce-157	135	13	were	be	AUX
globalce-157	135	14	categorized	categorize	VERB
globalce-157	135	15	as	as	ADP
globalce-157	135	16	injuries	injury	NOUN
globalce-157	135	17	(	(	PUNCT
globalce-157	135	18	98.4	98.4	NUM
globalce-157	135	19	%	%	NOUN
globalce-157	135	20	)	)	PUNCT
globalce-157	135	21	.	.	PUNCT
globalce-157	136	1	implantable	implantable	ADJ
globalce-157	136	2	defibrillators	defibrillator	NOUN
globalce-157	136	3	adverse	adverse	ADJ
globalce-157	136	4	events	event	NOUN
globalce-157	136	5	have	have	VERB
globalce-157	136	6	the	the	DET
globalce-157	136	7	highest	high	ADJ
globalce-157	136	8	probability	probability	NOUN
globalce-157	136	9	of	of	ADP
globalce-157	136	10	death	death	NOUN
globalce-157	136	11	(	(	PUNCT
globalce-157	136	12	3.2	3.2	NUM
globalce-157	136	13	%	%	NOUN
globalce-157	136	14	)	)	PUNCT
globalce-157	136	15	compared	compare	VERB
globalce-157	136	16	to	to	ADP
globalce-157	136	17	the	the	DET
globalce-157	136	18	rest	rest	NOUN
globalce-157	136	19	of	of	ADP
globalce-157	136	20	the	the	DET
globalce-157	136	21	examined	examine	VERB
globalce-157	136	22	device	device	NOUN
globalce-157	136	23	groups	group	NOUN
globalce-157	136	24	,	,	PUNCT
globalce-157	136	25	due	due	ADP
globalce-157	136	26	to	to	ADP
globalce-157	136	27	their	their	PRON
globalce-157	136	28	crucial	crucial	ADJ
globalce-157	136	29	role	role	NOUN
globalce-157	136	30	in	in	ADP
globalce-157	136	31	physiological	physiological	ADJ
globalce-157	136	32	heart	heart	NOUN
globalce-157	136	33	function	function	NOUN
globalce-157	136	34	.	.	PUNCT
globalce-157	137	1	finally	finally	ADV
globalce-157	137	2	,	,	PUNCT
globalce-157	137	3	most	most	ADJ
globalce-157	137	4	of	of	ADP
globalce-157	137	5	the	the	DET
globalce-157	137	6	reports	report	NOUN
globalce-157	137	7	regarding	regard	VERB
globalce-157	137	8	infusion	infusion	NOUN
globalce-157	137	9	pumps	pump	NOUN
globalce-157	137	10	(	(	PUNCT
globalce-157	137	11	over	over	ADP
globalce-157	137	12	98	98	NUM
globalce-157	137	13	%	%	NOUN
globalce-157	137	14	)	)	PUNCT
globalce-157	137	15	were	be	AUX
globalce-157	137	16	about	about	ADV
globalce-157	137	17	simple	simple	ADJ
globalce-157	137	18	device	device	NOUN
globalce-157	137	19	malfunctions	malfunction	NOUN
globalce-157	137	20	.	.	PUNCT
globalce-157	138	1	figure	figure	VERB
globalce-157	138	2	4	4	NUM
globalce-157	138	3	shows	show	VERB
globalce-157	138	4	that	that	SCONJ
globalce-157	138	5	most	most	ADJ
globalce-157	138	6	reports	report	NOUN
globalce-157	138	7	have	have	VERB
globalce-157	138	8	no	no	DET
globalce-157	138	9	remedial	remedial	ADJ
globalce-157	138	10	action	action	NOUN
globalce-157	138	11	connected	connect	VERB
globalce-157	138	12	with	with	ADP
globalce-157	138	13	them	they	PRON
globalce-157	138	14	(	(	PUNCT
globalce-157	138	15	80	80	NUM
globalce-157	138	16	%	%	NOUN
globalce-157	138	17	)	)	PUNCT
globalce-157	138	18	.	.	PUNCT
globalce-157	139	1	nevertheless	nevertheless	ADV
globalce-157	139	2	,	,	PUNCT
globalce-157	139	3	for	for	ADP
globalce-157	139	4	the	the	DET
globalce-157	139	5	remaining	remain	VERB
globalce-157	139	6	20	20	NUM
globalce-157	139	7	%	%	NOUN
globalce-157	139	8	,	,	PUNCT
globalce-157	139	9	where	where	SCONJ
globalce-157	139	10	information	information	NOUN
globalce-157	139	11	is	be	AUX
globalce-157	139	12	available	available	ADJ
globalce-157	139	13	,	,	PUNCT
globalce-157	139	14	the	the	DET
globalce-157	139	15	most	most	ADV
globalce-157	139	16	common	common	ADJ
globalce-157	139	17	action	action	NOUN
globalce-157	139	18	happens	happen	VERB
globalce-157	139	19	to	to	PART
globalce-157	139	20	be	be	AUX
globalce-157	139	21	a	a	DET
globalce-157	139	22	recall	recall	NOUN
globalce-157	139	23	,	,	PUNCT
globalce-157	139	24	which	which	PRON
globalce-157	139	25	is	be	AUX
globalce-157	139	26	associated	associate	VERB
globalce-157	139	27	with	with	ADP
globalce-157	139	28	three	three	NUM
globalce-157	139	29	-	-	PUNCT
globalce-157	139	30	quarters	quarter	NOUN
globalce-157	139	31	of	of	ADP
globalce-157	139	32	adverse	adverse	ADJ
globalce-157	139	33	events	event	NOUN
globalce-157	139	34	(	(	PUNCT
globalce-157	139	35	table	table	NOUN
globalce-157	139	36	3	3	NUM
globalce-157	139	37	)	)	PUNCT
globalce-157	139	38	.	.	PUNCT
globalce-157	140	1	repair	repair	NOUN
globalce-157	140	2	of	of	ADP
globalce-157	140	3	the	the	DET
globalce-157	140	4	affected	affect	VERB
globalce-157	140	5	devices	device	NOUN
globalce-157	140	6	was	be	AUX
globalce-157	140	7	a	a	DET
globalce-157	140	8	common	common	ADJ
globalce-157	140	9	action	action	NOUN
globalce-157	140	10	during	during	ADP
globalce-157	140	11	2011	2011	NUM
globalce-157	140	12	,	,	PUNCT
globalce-157	140	13	2013	2013	NUM
globalce-157	140	14	and	and	CCONJ
globalce-157	140	15	2014	2014	NUM
globalce-157	140	16	and	and	CCONJ
globalce-157	140	17	may	may	AUX
globalce-157	140	18	depend	depend	VERB
globalce-157	140	19	on	on	ADP
globalce-157	140	20	the	the	DET
globalce-157	140	21	types	type	NOUN
globalce-157	140	22	of	of	ADP
globalce-157	140	23	affected	affected	ADJ
globalce-157	140	24	devices	device	NOUN
globalce-157	140	25	.	.	PUNCT
globalce-157	141	1	actions	action	NOUN
globalce-157	141	2	categorized	categorize	VERB
globalce-157	141	3	as	as	ADP
globalce-157	141	4	“	"	PUNCT
globalce-157	141	5	other	other	ADJ
globalce-157	141	6	”	"	PUNCT
globalce-157	141	7	were	be	AUX
globalce-157	141	8	more	more	ADV
globalce-157	141	9	common	common	ADJ
globalce-157	141	10	until	until	ADP
globalce-157	141	11	the	the	DET
globalce-157	141	12	mid	mid	ADJ
globalce-157	141	13	‘	‘	X
globalce-157	141	14	10s	10	NOUN
globalce-157	141	15	,	,	PUNCT
globalce-157	141	16	while	while	SCONJ
globalce-157	141	17	being	be	AUX
globalce-157	141	18	the	the	DET
globalce-157	141	19	most	most	ADV
globalce-157	141	20	common	common	ADJ
globalce-157	141	21	remedial	remedial	ADJ
globalce-157	141	22	action	action	NOUN
globalce-157	141	23	during	during	ADP
globalce-157	141	24	the	the	DET
globalce-157	141	25	older	old	ADJ
globalce-157	141	26	years	year	NOUN
globalce-157	141	27	.	.	PUNCT
globalce-157	142	1	recently	recently	ADV
globalce-157	142	2	,	,	PUNCT
globalce-157	142	3	the	the	DET
globalce-157	142	4	“	"	PUNCT
globalce-157	142	5	other	other	ADJ
globalce-157	142	6	”	"	PUNCT
globalce-157	142	7	category	category	NOUN
globalce-157	142	8	stopped	stop	VERB
globalce-157	142	9	being	be	AUX
globalce-157	142	10	used	use	VERB
globalce-157	142	11	so	so	ADV
globalce-157	142	12	frequently	frequently	ADV
globalce-157	142	13	(	(	PUNCT
globalce-157	142	14	7	7	NUM
globalce-157	142	15	%	%	NOUN
globalce-157	142	16	of	of	ADP
globalce-157	142	17	total	total	ADJ
globalce-157	142	18	reports	report	NOUN
globalce-157	142	19	)	)	PUNCT
globalce-157	142	20	.	.	PUNCT
globalce-157	143	1	remedial	remedial	ADJ
globalce-157	143	2	actions	action	NOUN
globalce-157	143	3	different	different	ADJ
globalce-157	143	4	md	md	PROPN
globalce-157	143	5	groups	group	NOUN
globalce-157	143	6	are	be	AUX
globalce-157	143	7	associated	associate	VERB
globalce-157	143	8	with	with	ADP
globalce-157	143	9	different	different	ADJ
globalce-157	143	10	remedial	remedial	ADJ
globalce-157	143	11	actions	action	NOUN
globalce-157	143	12	(	(	PUNCT
globalce-157	143	13	table	table	NOUN
globalce-157	143	14	3	3	NUM
globalce-157	143	15	)	)	PUNCT
globalce-157	143	16	.	.	PUNCT
globalce-157	144	1	for	for	ADP
globalce-157	144	2	example	example	NOUN
globalce-157	144	3	,	,	PUNCT
globalce-157	144	4	reports	report	NOUN
globalce-157	144	5	involving	involve	VERB
globalce-157	144	6	continuous	continuous	ADJ
globalce-157	144	7	glucose	glucose	NOUN
globalce-157	144	8	monitoring	monitoring	NOUN
globalce-157	144	9	devices	device	NOUN
globalce-157	144	10	and	and	CCONJ
globalce-157	144	11	infusion	infusion	NOUN
globalce-157	144	12	pumps	pump	NOUN
globalce-157	144	13	resulted	result	VERB
globalce-157	144	14	in	in	ADP
globalce-157	144	15	a	a	DET
globalce-157	144	16	recall	recall	NOUN
globalce-157	144	17	action	action	NOUN
globalce-157	144	18	by	by	ADP
globalce-157	144	19	the	the	DET
globalce-157	144	20	manufacturer	manufacturer	NOUN
globalce-157	144	21	or	or	CCONJ
globalce-157	144	22	fda	fda	PROPN
globalce-157	144	23	9	9	NUM
globalce-157	144	24	out	out	ADP
globalce-157	144	25	of	of	ADP
globalce-157	144	26	10	10	NUM
globalce-157	144	27	times	time	NOUN
globalce-157	144	28	.	.	PUNCT
globalce-157	145	1	on	on	ADP
globalce-157	145	2	the	the	DET
globalce-157	145	3	other	other	ADJ
globalce-157	145	4	hand	hand	NOUN
globalce-157	145	5	,	,	PUNCT
globalce-157	145	6	dental	dental	ADJ
globalce-157	145	7	implants	implant	NOUN
globalce-157	145	8	resulted	result	VERB
globalce-157	145	9	in	in	ADP
globalce-157	145	10	almost	almost	ADV
globalce-157	145	11	no	no	PRON
globalce-157	145	12	recalls	recall	NOUN
globalce-157	145	13	,	,	PUNCT
globalce-157	145	14	and	and	CCONJ
globalce-157	145	15	the	the	DET
globalce-157	145	16	main	main	ADJ
globalce-157	145	17	action	action	NOUN
globalce-157	145	18	taken	take	VERB
globalce-157	145	19	by	by	ADP
globalce-157	145	20	the	the	DET
globalce-157	145	21	manufacturers	manufacturer	NOUN
globalce-157	145	22	was	be	AUX
globalce-157	145	23	either	either	CCONJ
globalce-157	145	24	an	an	DET
globalce-157	145	25	inspection	inspection	NOUN
globalce-157	145	26	(	(	PUNCT
globalce-157	145	27	69.7	69.7	NUM
globalce-157	145	28	%	%	NOUN
globalce-157	145	29	)	)	PUNCT
globalce-157	145	30	or	or	CCONJ
globalce-157	145	31	replacement	replacement	NOUN
globalce-157	145	32	of	of	ADP
globalce-157	145	33	the	the	DET
globalce-157	145	34	implant	implant	NOUN
globalce-157	145	35	(	(	PUNCT
globalce-157	145	36	26.0	26.0	NUM
globalce-157	145	37	%	%	NOUN
globalce-157	145	38	)	)	PUNCT
globalce-157	145	39	.	.	PUNCT
globalce-157	146	1	finally	finally	ADV
globalce-157	146	2	,	,	PUNCT
globalce-157	146	3	about	about	ADV
globalce-157	146	4	1	1	NUM
globalce-157	146	5	out	out	ADP
globalce-157	146	6	of	of	ADP
globalce-157	146	7	10	10	NUM
globalce-157	146	8	reports	report	NOUN
globalce-157	146	9	about	about	ADP
globalce-157	146	10	glucose	glucose	NOUN
globalce-157	146	11	test	test	NOUN
globalce-157	146	12	device	device	NOUN
globalce-157	146	13	groups	group	NOUN
globalce-157	146	14	led	lead	VERB
globalce-157	146	15	to	to	ADP
globalce-157	146	16	a	a	DET
globalce-157	146	17	recall	recall	NOUN
globalce-157	146	18	,	,	PUNCT
globalce-157	146	19	as	as	SCONJ
globalce-157	146	20	devices	device	NOUN
globalce-157	146	21	like	like	ADP
globalce-157	146	22	test	test	NOUN
globalce-157	146	23	strips	strip	NOUN
globalce-157	146	24	are	be	AUX
globalce-157	146	25	not	not	PART
globalce-157	146	26	so	so	ADV
globalce-157	146	27	crucial	crucial	ADJ
globalce-157	146	28	to	to	PART
globalce-157	146	29	patient	patient	VERB
globalce-157	146	30	safety	safety	NOUN
globalce-157	146	31	compared	compare	VERB
globalce-157	146	32	to	to	ADP
globalce-157	146	33	previously	previously	ADV
globalce-157	146	34	referred	refer	VERB
globalce-157	146	35	devices	device	NOUN
globalce-157	146	36	.	.	PUNCT
globalce-157	147	1	replacement	replacement	NOUN
globalce-157	147	2	(	(	PUNCT
globalce-157	147	3	38.0	38.0	NUM
globalce-157	147	4	%	%	NOUN
globalce-157	147	5	)	)	PUNCT
globalce-157	147	6	,	,	PUNCT
globalce-157	147	7	notification	notification	NOUN
globalce-157	147	8	(	(	PUNCT
globalce-157	147	9	28.6	28.6	NUM
globalce-157	147	10	%	%	NOUN
globalce-157	147	11	)	)	PUNCT
globalce-157	147	12	and	and	CCONJ
globalce-157	147	13	other	other	ADJ
globalce-157	147	14	(	(	PUNCT
globalce-157	147	15	23.3	23.3	NUM
globalce-157	147	16	%	%	NOUN
globalce-157	147	17	)	)	PUNCT
globalce-157	147	18	were	be	AUX
globalce-157	147	19	the	the	DET
globalce-157	147	20	most	most	ADV
globalce-157	147	21	frequent	frequent	ADJ
globalce-157	147	22	remedial	remedial	ADJ
globalce-157	147	23	actions	action	NOUN
globalce-157	147	24	for	for	ADP
globalce-157	147	25	dealing	deal	VERB
globalce-157	147	26	with	with	ADP
globalce-157	147	27	issues	issue	NOUN
globalce-157	147	28	such	such	ADJ
globalce-157	147	29	as	as	ADP
globalce-157	147	30	incorrect	incorrect	ADJ
globalce-157	147	31	measurements	measurement	NOUN
globalce-157	147	32	.	.	PUNCT
globalce-157	148	1	figure	figure	VERB
globalce-157	148	2	3	3	NUM
globalce-157	148	3	.	.	PUNCT
globalce-157	148	4	adverse	adverse	ADJ
globalce-157	148	5	event	event	NOUN
globalce-157	148	6	types	type	NOUN
globalce-157	148	7	.	.	PUNCT
globalce-157	149	1	number	number	NOUN
globalce-157	149	2	of	of	ADP
globalce-157	149	3	reports(top	reports(top	NOUN
globalce-157	149	4	)	)	PUNCT
globalce-157	149	5	and	and	CCONJ
globalce-157	149	6	percentage	percentage	NOUN
globalce-157	149	7	evolution(bottom	evolution(bottom	PROPN
globalce-157	149	8	)	)	PUNCT
globalce-157	149	9	.	.	PUNCT
globalce-157	150	1	zisimopoulos	zisimopoulo	NOUN
globalce-157	150	2	,	,	PUNCT
globalce-157	150	3	pallikarakis	pallikarakis	PROPN
globalce-157	150	4	:	:	PUNCT
globalce-157	150	5	an	an	DET
globalce-157	150	6	analysis	analysis	NOUN
globalce-157	150	7	of	of	ADP
globalce-157	150	8	adverse	adverse	ADJ
globalce-157	150	9	event	event	NOUN
globalce-157	150	10	reports	report	NOUN
globalce-157	150	11	in	in	ADP
globalce-157	150	12	fda	fda	PROPN
globalce-157	150	13	’s	’s	PART
globalce-157	150	14	maude	maude	PROPN
globalce-157	150	15	database	database	PROPN
globalce-157	150	16	j	j	PROPN
globalce-157	150	17	global	global	ADJ
globalce-157	150	18	clinical	clinical	ADJ
globalce-157	150	19	engineering	engineering	PROPN
globalce-157	150	20	vol.6	vol.6	PROPN
globalce-157	150	21	issue	issue	NOUN
globalce-157	150	22	1	1	NUM
globalce-157	150	23	:	:	SYM
globalce-157	150	24	2023	2023	NUM
globalce-157	150	25	12	12	NUM
globalce-157	150	26	report	report	NOUN
globalce-157	150	27	source	source	VERB
globalce-157	150	28	the	the	DET
globalce-157	150	29	majority	majority	NOUN
globalce-157	150	30	of	of	ADP
globalce-157	150	31	the	the	DET
globalce-157	150	32	total	total	ADJ
globalce-157	150	33	reports	report	NOUN
globalce-157	150	34	(	(	PUNCT
globalce-157	150	35	96	96	NUM
globalce-157	150	36	%	%	NOUN
globalce-157	150	37	)	)	PUNCT
globalce-157	150	38	were	be	AUX
globalce-157	150	39	filed	file	VERB
globalce-157	150	40	by	by	ADP
globalce-157	150	41	the	the	DET
globalce-157	150	42	device	device	NOUN
globalce-157	150	43	manufacturers	manufacturer	NOUN
globalce-157	150	44	,	,	PUNCT
globalce-157	150	45	as	as	SCONJ
globalce-157	150	46	shown	show	VERB
globalce-157	150	47	in	in	ADP
globalce-157	150	48	figure	figure	NOUN
globalce-157	150	49	5	5	NUM
globalce-157	150	50	.	.	PUNCT
globalce-157	151	1	this	this	PRON
globalce-157	151	2	concerns	concern	VERB
globalce-157	151	3	the	the	DET
globalce-157	151	4	stricter	strict	ADJ
globalce-157	151	5	requirements	requirement	NOUN
globalce-157	151	6	about	about	ADP
globalce-157	151	7	adverse	adverse	ADJ
globalce-157	151	8	event	event	NOUN
globalce-157	151	9	reporting	report	VERB
globalce-157	151	10	imposed	impose	VERB
globalce-157	151	11	on	on	ADP
globalce-157	151	12	manufacturers	manufacturer	NOUN
globalce-157	151	13	.	.	PUNCT
globalce-157	152	1	in	in	ADP
globalce-157	152	2	the	the	DET
globalce-157	152	3	last	last	ADJ
globalce-157	152	4	4	4	NUM
globalce-157	152	5	years	year	NOUN
globalce-157	152	6	there	there	PRON
globalce-157	152	7	has	have	AUX
globalce-157	152	8	been	be	AUX
globalce-157	152	9	an	an	DET
globalce-157	152	10	increase	increase	NOUN
globalce-157	152	11	in	in	ADP
globalce-157	152	12	distributor	distributor	NOUN
globalce-157	152	13	reports	report	NOUN
globalce-157	152	14	.	.	PUNCT
globalce-157	153	1	during	during	ADP
globalce-157	153	2	these	these	DET
globalce-157	153	3	years	year	NOUN
globalce-157	153	4	,	,	PUNCT
globalce-157	153	5	dental	dental	ADJ
globalce-157	153	6	implants	implant	NOUN
globalce-157	153	7	and	and	CCONJ
globalce-157	153	8	implantable	implantable	ADJ
globalce-157	153	9	defibrillators	defibrillator	NOUN
globalce-157	153	10	were	be	AUX
globalce-157	153	11	the	the	DET
globalce-157	153	12	main	main	ADJ
globalce-157	153	13	types	type	NOUN
globalce-157	153	14	of	of	ADP
globalce-157	153	15	devices	device	NOUN
globalce-157	153	16	reported	report	VERB
globalce-157	153	17	.	.	PUNCT
globalce-157	154	1	initial	initial	ADJ
globalce-157	154	2	reporter	reporter	NOUN
globalce-157	154	3	occupation	occupation	NOUN
globalce-157	154	4	figure	figure	NOUN
globalce-157	154	5	6	6	NUM
globalce-157	154	6	presents	present	VERB
globalce-157	154	7	the	the	DET
globalce-157	154	8	occupation	occupation	NOUN
globalce-157	154	9	of	of	ADP
globalce-157	154	10	the	the	DET
globalce-157	154	11	initial	initial	ADJ
globalce-157	154	12	adverse	adverse	ADJ
globalce-157	154	13	event	event	NOUN
globalce-157	154	14	reporter	reporter	NOUN
globalce-157	154	15	.	.	PUNCT
globalce-157	155	1	the	the	DET
globalce-157	155	2	initial	initial	ADJ
globalce-157	155	3	reporter	reporter	NOUN
globalce-157	155	4	may	may	AUX
globalce-157	155	5	be	be	AUX
globalce-157	155	6	different	different	ADJ
globalce-157	155	7	than	than	ADP
globalce-157	155	8	the	the	DET
globalce-157	155	9	one	one	NOUN
globalce-157	155	10	that	that	PRON
globalce-157	155	11	submits	submit	VERB
globalce-157	155	12	the	the	DET
globalce-157	155	13	final	final	ADJ
globalce-157	155	14	report	report	NOUN
globalce-157	155	15	to	to	ADP
globalce-157	155	16	fda	fda	PROPN
globalce-157	155	17	,	,	PUNCT
globalce-157	155	18	like	like	ADP
globalce-157	155	19	in	in	ADP
globalce-157	155	20	the	the	DET
globalce-157	155	21	case	case	NOUN
globalce-157	155	22	when	when	SCONJ
globalce-157	155	23	a	a	DET
globalce-157	155	24	user	user	NOUN
globalce-157	155	25	of	of	ADP
globalce-157	155	26	a	a	DET
globalce-157	155	27	medical	medical	ADJ
globalce-157	155	28	device	device	NOUN
globalce-157	155	29	notifies	notifie	NOUN
globalce-157	155	30	an	an	DET
globalce-157	155	31	event	event	NOUN
globalce-157	155	32	to	to	ADP
globalce-157	155	33	its	its	PRON
globalce-157	155	34	manufacturer	manufacturer	NOUN
globalce-157	155	35	,	,	PUNCT
globalce-157	155	36	who	who	PRON
globalce-157	155	37	is	be	AUX
globalce-157	155	38	then	then	ADV
globalce-157	155	39	obligated	obligate	VERB
globalce-157	155	40	to	to	PART
globalce-157	155	41	file	file	VERB
globalce-157	155	42	an	an	DET
globalce-157	155	43	official	official	ADJ
globalce-157	155	44	report	report	NOUN
globalce-157	155	45	to	to	ADP
globalce-157	155	46	the	the	DET
globalce-157	155	47	fda	fda	PROPN
globalce-157	155	48	.	.	PUNCT
globalce-157	156	1	physicians	physician	NOUN
globalce-157	156	2	and	and	CCONJ
globalce-157	156	3	other	other	ADJ
globalce-157	156	4	health	health	NOUN
globalce-157	156	5	care	care	NOUN
globalce-157	156	6	professionals	professional	NOUN
globalce-157	156	7	have	have	VERB
globalce-157	156	8	a	a	DET
globalce-157	156	9	constant	constant	ADJ
globalce-157	156	10	rate	rate	NOUN
globalce-157	156	11	of	of	ADP
globalce-157	156	12	reporting	report	VERB
globalce-157	156	13	adverse	adverse	ADJ
globalce-157	156	14	events	event	NOUN
globalce-157	156	15	.	.	PUNCT
globalce-157	157	1	in	in	ADP
globalce-157	157	2	the	the	DET
globalce-157	157	3	years	year	NOUN
globalce-157	157	4	2012	2012	NUM
globalce-157	157	5	and	and	CCONJ
globalce-157	157	6	2013	2013	NUM
globalce-157	157	7	,	,	PUNCT
globalce-157	157	8	a	a	DET
globalce-157	157	9	considerable	considerable	ADJ
globalce-157	157	10	number	number	NOUN
globalce-157	157	11	of	of	ADP
globalce-157	157	12	events	event	NOUN
globalce-157	157	13	were	be	AUX
globalce-157	157	14	reported	report	VERB
globalce-157	157	15	by	by	ADP
globalce-157	157	16	attorneys	attorney	NOUN
globalce-157	157	17	.	.	PUNCT
globalce-157	158	1	this	this	PRON
globalce-157	158	2	was	be	AUX
globalce-157	158	3	the	the	DET
globalce-157	158	4	period	period	NOUN
globalce-157	158	5	of	of	ADP
globalce-157	158	6	lawsuits	lawsuit	NOUN
globalce-157	158	7	filed	file	VERB
globalce-157	158	8	against	against	ADP
globalce-157	158	9	metal	metal	NOUN
globalce-157	158	10	-	-	PUNCT
globalce-157	158	11	on	on	ADP
globalce-157	158	12	-	-	PUNCT
globalce-157	158	13	metal	metal	NOUN
globalce-157	158	14	hip	hip	NOUN
globalce-157	158	15	prosthetics	prosthetic	NOUN
globalce-157	158	16	manufacturers.18,19	manufacturers.18,19	NOUN
globalce-157	158	17	between	between	ADP
globalce-157	158	18	2013	2013	NUM
globalce-157	158	19	and	and	CCONJ
globalce-157	158	20	2018	2018	NUM
globalce-157	158	21	about	about	ADV
globalce-157	158	22	15	15	NUM
globalce-157	158	23	%	%	NOUN
globalce-157	158	24	of	of	ADP
globalce-157	158	25	reports	report	NOUN
globalce-157	158	26	(	(	PUNCT
globalce-157	158	27	peaking	peak	VERB
globalce-157	158	28	at	at	ADP
globalce-157	158	29	21	21	NUM
globalce-157	158	30	%	%	NOUN
globalce-157	158	31	in	in	ADP
globalce-157	158	32	2016	2016	NUM
globalce-157	158	33	)	)	PUNCT
globalce-157	158	34	were	be	AUX
globalce-157	158	35	made	make	VERB
globalce-157	158	36	by	by	ADP
globalce-157	158	37	the	the	DET
globalce-157	158	38	patients	patient	NOUN
globalce-157	158	39	themselves	themselves	PRON
globalce-157	158	40	.	.	PUNCT
globalce-157	159	1	during	during	ADP
globalce-157	159	2	this	this	DET
globalce-157	159	3	period	period	NOUN
globalce-157	159	4	,	,	PUNCT
globalce-157	159	5	insulin	insulin	NOUN
globalce-157	159	6	pumps	pump	NOUN
globalce-157	159	7	and	and	CCONJ
globalce-157	159	8	glucose	glucose	NOUN
globalce-157	159	9	sensor	sensor	NOUN
globalce-157	159	10	events	event	NOUN
globalce-157	159	11	were	be	AUX
globalce-157	159	12	predominant	predominant	ADJ
globalce-157	159	13	,	,	PUNCT
globalce-157	159	14	so	so	SCONJ
globalce-157	159	15	it	it	PRON
globalce-157	159	16	makes	make	VERB
globalce-157	159	17	sense	sense	NOUN
globalce-157	159	18	that	that	SCONJ
globalce-157	159	19	home	home	NOUN
globalce-157	159	20	users	user	NOUN
globalce-157	159	21	initially	initially	ADV
globalce-157	159	22	made	make	VERB
globalce-157	159	23	a	a	DET
globalce-157	159	24	lot	lot	NOUN
globalce-157	159	25	of	of	ADP
globalce-157	159	26	the	the	DET
globalce-157	159	27	reports	report	NOUN
globalce-157	159	28	.	.	PUNCT
globalce-157	160	1	an	an	DET
globalce-157	160	2	increase	increase	NOUN
globalce-157	160	3	in	in	ADP
globalce-157	160	4	the	the	DET
globalce-157	160	5	percentage	percentage	NOUN
globalce-157	160	6	of	of	ADP
globalce-157	160	7	reports	report	NOUN
globalce-157	160	8	initially	initially	ADV
globalce-157	160	9	submitted	submit	VERB
globalce-157	160	10	by	by	ADP
globalce-157	160	11	dentists	dentist	NOUN
globalce-157	160	12	can	can	AUX
globalce-157	160	13	be	be	AUX
globalce-157	160	14	observed	observe	VERB
globalce-157	160	15	after	after	ADP
globalce-157	160	16	2019	2019	NUM
globalce-157	160	17	.	.	PUNCT
globalce-157	161	1	deeper	deep	ADJ
globalce-157	161	2	analysis	analysis	NOUN
globalce-157	161	3	showed	show	VERB
globalce-157	161	4	figure	figure	NOUN
globalce-157	161	5	4	4	NUM
globalce-157	161	6	.	.	PUNCT
globalce-157	162	1	adverse	adverse	ADJ
globalce-157	162	2	event	event	NOUN
globalce-157	162	3	remedial	remedial	ADJ
globalce-157	162	4	actions	action	NOUN
globalce-157	162	5	.	.	PUNCT
globalce-157	163	1	table	table	NOUN
globalce-157	164	1	3	3	NUM
globalce-157	164	2	.	.	PUNCT
globalce-157	165	1	adverse	adverse	ADJ
globalce-157	165	2	event	event	NOUN
globalce-157	165	3	remedial	remedial	ADJ
globalce-157	165	4	action	action	NOUN
globalce-157	165	5	distribution	distribution	NOUN
globalce-157	165	6	for	for	ADP
globalce-157	165	7	various	various	ADJ
globalce-157	165	8	md	md	PROPN
globalce-157	165	9	groupss	groupss	PROPN
globalce-157	165	10	remedial	remedial	ADJ
globalce-157	165	11	action	action	NOUN
globalce-157	165	12	(	(	PUNCT
globalce-157	165	13	%	%	INTJ
globalce-157	165	14	)	)	PUNCT
globalce-157	165	15	recall	recall	NOUN
globalce-157	165	16	repair	repair	NOUN
globalce-157	165	17	replace	replace	NOUN
globalce-157	165	18	relabeling	relabele	VERB
globalce-157	165	19	other	other	ADJ
globalce-157	165	20	notification	notification	NOUN
globalce-157	165	21	inspection	inspection	NOUN
globalce-157	165	22	patient	patient	NOUN
globalce-157	165	23	monitoring	monitor	VERB
globalce-157	165	24	modification/	modification/	NUM
globalce-157	165	25	adjustment	adjustment	NOUN
globalce-157	165	26	glucose	glucose	NOUN
globalce-157	165	27	monitoring	monitoring	NOUN
globalce-157	165	28	[	[	X
globalce-157	165	29	'	'	PUNCT
globalce-157	165	30	mds	mds	NOUN
globalce-157	165	31	'	'	PUNCT
globalce-157	165	32	,	,	PUNCT
globalce-157	165	33	'	'	PUNCT
globalce-157	165	34	oyc	oyc	PROPN
globalce-157	165	35	'	'	PUNCT
globalce-157	165	36	,	,	PUNCT
globalce-157	165	37	'	'	PUNCT
globalce-157	165	38	pqf	pqf	NOUN
globalce-157	165	39	'	'	PUNCT
globalce-157	165	40	]	]	PUNCT
globalce-157	165	41	93.58	93.58	NUM
globalce-157	165	42	0.01	0.01	NUM
globalce-157	165	43	4.27	4.27	NUM
globalce-157	165	44	0.01	0.01	NUM
globalce-157	165	45	0.12	0.12	NUM
globalce-157	165	46	1.99	1.99	NUM
globalce-157	165	47	0.01	0.01	NUM
globalce-157	165	48	0.01	0.01	NUM
globalce-157	165	49	≈	≈	PROPN
globalce-157	165	50	0.0	0.0	NUM
globalce-157	165	51	glucose	glucose	NOUN
globalce-157	165	52	test	test	NOUN
globalce-157	165	53	[	[	X
globalce-157	165	54	'	'	PUNCT
globalce-157	165	55	cfr	cfr	NOUN
globalce-157	165	56	'	'	PUNCT
globalce-157	165	57	,	,	PUNCT
globalce-157	165	58	'	'	PUNCT
globalce-157	165	59	lfr	lfr	PROPN
globalce-157	165	60	'	'	PUNCT
globalce-157	165	61	,	,	PUNCT
globalce-157	165	62	'	'	PUNCT
globalce-157	165	63	nbw	nbw	ADJ
globalce-157	165	64	'	'	PUNCT
globalce-157	165	65	]	]	PUNCT
globalce-157	165	66	9.55	9.55	NUM
globalce-157	165	67	0.10	0.10	NUM
globalce-157	165	68	38.03	38.03	NUM
globalce-157	165	69	0.02	0.02	NUM
globalce-157	165	70	23.27	23.27	NUM
globalce-157	165	71	28.60	28.60	NUM
globalce-157	165	72	0.02	0.02	NUM
globalce-157	166	1	≈	≈	PROPN
globalce-157	166	2	0.0	0.0	NUM
globalce-157	166	3	0.40	0.40	NUM
globalce-157	166	4	pump	pump	NOUN
globalce-157	166	5	,	,	PUNCT
globalce-157	166	6	infusion	infusion	NOUN
globalce-157	166	7	89.86	89.86	NUM
globalce-157	166	8	9.53	9.53	NUM
globalce-157	166	9	0.05	0.05	NUM
globalce-157	166	10	≈	≈	PROPN
globalce-157	166	11	0.0	0.0	NUM
globalce-157	166	12	0.42	0.42	NUM
globalce-157	166	13	0.10	0.10	NUM
globalce-157	166	14	0.02	0.02	NUM
globalce-157	167	1	≈	≈	PROPN
globalce-157	167	2	0.0	0.0	NUM
globalce-157	167	3	0.03	0.03	NUM
globalce-157	167	4	implant	implant	NOUN
globalce-157	167	5	,	,	PUNCT
globalce-157	167	6	endosseous	endosseous	ADJ
globalce-157	167	7	,	,	PUNCT
globalce-157	167	8	root	root	NOUN
globalce-157	167	9	-	-	PUNCT
globalce-157	167	10	form	form	NOUN
globalce-157	167	11	0.36	0.36	NUM
globalce-157	167	12	0.03	0.03	NUM
globalce-157	167	13	26.04	26.04	NUM
globalce-157	167	14	0.02	0.02	NUM
globalce-157	167	15	3.76	3.76	NUM
globalce-157	167	16	0.06	0.06	NUM
globalce-157	167	17	69.66	69.66	NUM
globalce-157	167	18	0.06	0.06	NUM
globalce-157	167	19	0.01	0.01	NUM
globalce-157	167	20	average	average	NOUN
globalce-157	167	21	for	for	ADP
globalce-157	167	22	all	all	DET
globalce-157	167	23	device	device	NOUN
globalce-157	167	24	groups	group	NOUN
globalce-157	167	25	74.0	74.0	NUM
globalce-157	167	26	7.0	7.0	NUM
globalce-157	167	27	5.5	5.5	NUM
globalce-157	167	28	≈0.1	≈0.1	NUM
globalce-157	167	29	7.0	7.0	NUM
globalce-157	167	30	3.6	3.6	NUM
globalce-157	167	31	2.1	2.1	NUM
globalce-157	167	32	0.2	0.2	NUM
globalce-157	167	33	0.5	0.5	NUM
globalce-157	167	34	13	13	NUM
globalce-157	167	35	j	j	PROPN
globalce-157	167	36	global	global	ADJ
globalce-157	167	37	clinical	clinical	ADJ
globalce-157	167	38	engineering	engineering	PROPN
globalce-157	167	39	vol.6	vol.6	PROPN
globalce-157	167	40	issue	issue	NOUN
globalce-157	167	41	1	1	NUM
globalce-157	167	42	:	:	SYM
globalce-157	167	43	2023	2023	NUM
globalce-157	167	44	zisimopoulos	zisimopoulo	NOUN
globalce-157	167	45	,	,	PUNCT
globalce-157	167	46	pallikarakis	pallikarakis	PROPN
globalce-157	167	47	:	:	PUNCT
globalce-157	167	48	an	an	DET
globalce-157	167	49	analysis	analysis	NOUN
globalce-157	167	50	of	of	ADP
globalce-157	167	51	adverse	adverse	ADJ
globalce-157	167	52	event	event	NOUN
globalce-157	167	53	reports	report	NOUN
globalce-157	167	54	in	in	ADP
globalce-157	167	55	fda	fda	PROPN
globalce-157	167	56	’s	’s	PART
globalce-157	167	57	maude	maude	PROPN
globalce-157	167	58	database	database	NOUN
globalce-157	167	59	that	that	SCONJ
globalce-157	167	60	many	many	ADJ
globalce-157	167	61	of	of	ADP
globalce-157	167	62	the	the	DET
globalce-157	167	63	events	event	NOUN
globalce-157	167	64	were	be	AUX
globalce-157	167	65	caused	cause	VERB
globalce-157	167	66	by	by	ADP
globalce-157	167	67	dental	dental	ADJ
globalce-157	167	68	implants	implant	NOUN
globalce-157	167	69	(	(	PUNCT
globalce-157	167	70	peaking	peak	VERB
globalce-157	167	71	at	at	ADP
globalce-157	167	72	24	24	NUM
globalce-157	167	73	%	%	NOUN
globalce-157	167	74	of	of	ADP
globalce-157	167	75	the	the	DET
globalce-157	167	76	total	total	ADJ
globalce-157	167	77	reports	report	NOUN
globalce-157	167	78	in	in	ADP
globalce-157	167	79	2021	2021	NUM
globalce-157	167	80	)	)	PUNCT
globalce-157	167	81	during	during	ADP
globalce-157	167	82	the	the	DET
globalce-157	167	83	last	last	ADJ
globalce-157	167	84	4	4	NUM
globalce-157	167	85	years	year	NOUN
globalce-157	167	86	.	.	PUNCT
globalce-157	168	1	finally	finally	ADV
globalce-157	168	2	,	,	PUNCT
globalce-157	168	3	more	more	ADJ
globalce-157	168	4	events	event	NOUN
globalce-157	168	5	have	have	AUX
globalce-157	168	6	been	be	AUX
globalce-157	168	7	reported	report	VERB
globalce-157	168	8	in	in	ADP
globalce-157	168	9	the	the	DET
globalce-157	168	10	previous	previous	ADJ
globalce-157	168	11	five	five	NUM
globalce-157	168	12	years	year	NOUN
globalce-157	168	13	,	,	PUNCT
globalce-157	168	14	especially	especially	ADV
globalce-157	168	15	in	in	ADP
globalce-157	168	16	2022	2022	NUM
globalce-157	168	17	(	(	PUNCT
globalce-157	168	18	35	35	NUM
globalce-157	168	19	%	%	NOUN
globalce-157	168	20	)	)	PUNCT
globalce-157	168	21	,	,	PUNCT
globalce-157	168	22	by	by	ADP
globalce-157	168	23	other	other	ADJ
globalce-157	168	24	non	non	ADJ
globalce-157	168	25	-	-	ADJ
globalce-157	168	26	healthcare	healthcare	ADJ
globalce-157	168	27	professionals	professional	NOUN
globalce-157	168	28	than	than	ADP
globalce-157	168	29	in	in	ADP
globalce-157	168	30	the	the	DET
globalce-157	168	31	past	past	NOUN
globalce-157	168	32	.	.	PUNCT
globalce-157	169	1	device	device	NOUN
globalce-157	169	2	evaluated	evaluate	VERB
globalce-157	169	3	by	by	ADP
globalce-157	169	4	manufacturer	manufacturer	NOUN
globalce-157	169	5	figure	figure	NOUN
globalce-157	169	6	7	7	NUM
globalce-157	169	7	shows	show	VERB
globalce-157	169	8	the	the	DET
globalce-157	169	9	status	status	NOUN
globalce-157	169	10	of	of	ADP
globalce-157	169	11	reports	report	NOUN
globalce-157	169	12	as	as	ADV
globalce-157	169	13	far	far	ADV
globalce-157	169	14	as	as	SCONJ
globalce-157	169	15	the	the	DET
globalce-157	169	16	device	device	NOUN
globalce-157	169	17	evaluation	evaluation	NOUN
globalce-157	169	18	by	by	ADP
globalce-157	169	19	the	the	DET
globalce-157	169	20	manufacturer	manufacturer	NOUN
globalce-157	169	21	is	be	AUX
globalce-157	169	22	concerned	concern	VERB
globalce-157	169	23	.	.	PUNCT
globalce-157	170	1	more	more	ADJ
globalce-157	170	2	than	than	ADP
globalce-157	170	3	half	half	NOUN
globalce-157	170	4	of	of	ADP
globalce-157	170	5	the	the	DET
globalce-157	170	6	devices	device	NOUN
globalce-157	170	7	reported	report	VERB
globalce-157	170	8	(	(	PUNCT
globalce-157	170	9	52.3	52.3	NUM
globalce-157	170	10	%	%	NOUN
globalce-157	170	11	)	)	PUNCT
globalce-157	170	12	are	be	AUX
globalce-157	170	13	sent	send	VERB
globalce-157	170	14	to	to	ADP
globalce-157	170	15	the	the	DET
globalce-157	170	16	manufacturer	manufacturer	NOUN
globalce-157	170	17	,	,	PUNCT
globalce-157	170	18	and	and	CCONJ
globalce-157	170	19	most	most	ADJ
globalce-157	170	20	of	of	ADP
globalce-157	170	21	them	they	PRON
globalce-157	170	22	are	be	AUX
globalce-157	170	23	evaluated	evaluate	VERB
globalce-157	170	24	(	(	PUNCT
globalce-157	170	25	70.8	70.8	NUM
globalce-157	170	26	%	%	NOUN
globalce-157	170	27	of	of	ADP
globalce-157	170	28	sent	send	VERB
globalce-157	170	29	devices	device	NOUN
globalce-157	170	30	)	)	PUNCT
globalce-157	170	31	.	.	PUNCT
globalce-157	171	1	2022	2022	NUM
globalce-157	171	2	was	be	AUX
globalce-157	171	3	an	an	DET
globalce-157	171	4	exception	exception	NOUN
globalce-157	171	5	,	,	PUNCT
globalce-157	171	6	with	with	ADP
globalce-157	171	7	55	55	NUM
globalce-157	171	8	%	%	NOUN
globalce-157	171	9	of	of	ADP
globalce-157	171	10	the	the	DET
globalce-157	171	11	devices	device	NOUN
globalce-157	171	12	sent	send	VERB
globalce-157	171	13	to	to	ADP
globalce-157	171	14	the	the	DET
globalce-157	171	15	manufacturer	manufacturer	NOUN
globalce-157	171	16	not	not	PART
globalce-157	171	17	being	be	AUX
globalce-157	171	18	evaluated	evaluate	VERB
globalce-157	171	19	.	.	PUNCT
globalce-157	172	1	device	device	NOUN
globalce-157	172	2	age	age	NOUN
globalce-157	172	3	the	the	DET
globalce-157	172	4	mean	mean	ADJ
globalce-157	172	5	age	age	NOUN
globalce-157	172	6	of	of	ADP
globalce-157	172	7	the	the	DET
globalce-157	172	8	devices	device	NOUN
globalce-157	172	9	involved	involve	VERB
globalce-157	172	10	in	in	ADP
globalce-157	172	11	all	all	DET
globalce-157	172	12	adverse	adverse	ADJ
globalce-157	172	13	events	event	NOUN
globalce-157	172	14	of	of	ADP
globalce-157	172	15	the	the	DET
globalce-157	172	16	maude	maude	NOUN
globalce-157	172	17	database	database	NOUN
globalce-157	172	18	is	be	AUX
globalce-157	172	19	5.4	5.4	NUM
globalce-157	172	20	years	year	NOUN
globalce-157	172	21	.	.	PUNCT
globalce-157	173	1	however	however	ADV
globalce-157	173	2	,	,	PUNCT
globalce-157	173	3	this	this	DET
globalce-157	173	4	result	result	NOUN
globalce-157	173	5	is	be	AUX
globalce-157	173	6	strongly	strongly	ADV
globalce-157	173	7	influenced	influence	VERB
globalce-157	173	8	by	by	ADP
globalce-157	173	9	the	the	DET
globalce-157	173	10	impact	impact	NOUN
globalce-157	173	11	of	of	ADP
globalce-157	173	12	the	the	DET
globalce-157	173	13	last	last	ADJ
globalce-157	173	14	couple	couple	NOUN
globalce-157	173	15	of	of	ADP
globalce-157	173	16	years	year	NOUN
globalce-157	173	17	’	'	PUNCT
globalce-157	173	18	reports	report	NOUN
globalce-157	173	19	,	,	PUNCT
globalce-157	173	20	as	as	SCONJ
globalce-157	173	21	shown	show	VERB
globalce-157	173	22	in	in	ADP
globalce-157	173	23	figure	figure	NOUN
globalce-157	173	24	8	8	NUM
globalce-157	173	25	.	.	PUNCT
globalce-157	173	26	up	up	ADP
globalce-157	173	27	until	until	ADP
globalce-157	173	28	2019	2019	NUM
globalce-157	173	29	,	,	PUNCT
globalce-157	173	30	the	the	DET
globalce-157	173	31	average	average	ADJ
globalce-157	173	32	device	device	NOUN
globalce-157	173	33	age	age	NOUN
globalce-157	173	34	was	be	AUX
globalce-157	173	35	2.8	2.8	NUM
globalce-157	173	36	years	year	NOUN
globalce-157	173	37	.	.	PUNCT
globalce-157	174	1	the	the	DET
globalce-157	174	2	seeming	seem	VERB
globalce-157	174	3	rise	rise	NOUN
globalce-157	174	4	in	in	ADP
globalce-157	174	5	the	the	DET
globalce-157	174	6	device	device	NOUN
globalce-157	174	7	's	's	PART
globalce-157	174	8	age	age	NOUN
globalce-157	174	9	might	might	AUX
globalce-157	174	10	be	be	AUX
globalce-157	174	11	related	relate	VERB
globalce-157	174	12	to	to	ADP
globalce-157	174	13	the	the	DET
globalce-157	174	14	reported	report	VERB
globalce-157	174	15	devices	device	NOUN
globalce-157	174	16	'	'	PART
globalce-157	174	17	types	type	NOUN
globalce-157	174	18	.	.	PUNCT
globalce-157	175	1	most	most	ADJ
globalce-157	175	2	of	of	ADP
globalce-157	175	3	the	the	DET
globalce-157	175	4	events	event	NOUN
globalce-157	175	5	(	(	PUNCT
globalce-157	175	6	43	43	NUM
globalce-157	175	7	%	%	NOUN
globalce-157	175	8	)	)	PUNCT
globalce-157	175	9	are	be	AUX
globalce-157	175	10	associated	associate	VERB
globalce-157	175	11	with	with	ADP
globalce-157	175	12	devices	device	NOUN
globalce-157	175	13	during	during	ADP
globalce-157	175	14	their	their	PRON
globalce-157	175	15	first	first	ADJ
globalce-157	175	16	year	year	NOUN
globalce-157	175	17	of	of	ADP
globalce-157	175	18	operation	operation	NOUN
globalce-157	175	19	.	.	PUNCT
globalce-157	176	1	figure	figure	NOUN
globalce-157	176	2	5	5	NUM
globalce-157	176	3	.	.	PUNCT
globalce-157	176	4	adverse	adverse	ADJ
globalce-157	176	5	events	event	NOUN
globalce-157	176	6	report	report	NOUN
globalce-157	176	7	source	source	NOUN
globalce-157	176	8	.	.	PUNCT
globalce-157	177	1	figure	figure	NOUN
globalce-157	177	2	6	6	NUM
globalce-157	177	3	.	.	PUNCT
globalce-157	178	1	adverse	adverse	ADJ
globalce-157	178	2	event	event	NOUN
globalce-157	178	3	initial	initial	ADJ
globalce-157	178	4	reporter	reporter	NOUN
globalce-157	178	5	occupation	occupation	NOUN
globalce-157	178	6	.	.	PUNCT
globalce-157	179	1	figure	figure	VERB
globalce-157	179	2	7	7	NUM
globalce-157	179	3	.	.	PUNCT
globalce-157	179	4	device	device	NOUN
globalce-157	179	5	evaluation	evaluation	NOUN
globalce-157	179	6	by	by	ADP
globalce-157	179	7	manufacturers	manufacturer	NOUN
globalce-157	179	8	.	.	PUNCT
globalce-157	180	1	zisimopoulos	zisimopoulo	NOUN
globalce-157	180	2	,	,	PUNCT
globalce-157	180	3	pallikarakis	pallikarakis	PROPN
globalce-157	180	4	:	:	PUNCT
globalce-157	180	5	an	an	DET
globalce-157	180	6	analysis	analysis	NOUN
globalce-157	180	7	of	of	ADP
globalce-157	180	8	adverse	adverse	ADJ
globalce-157	180	9	event	event	NOUN
globalce-157	180	10	reports	report	NOUN
globalce-157	180	11	in	in	ADP
globalce-157	180	12	fda	fda	PROPN
globalce-157	180	13	’s	’s	PART
globalce-157	180	14	maude	maude	PROPN
globalce-157	180	15	database	database	PROPN
globalce-157	180	16	j	j	PROPN
globalce-157	181	1	global	global	ADJ
globalce-157	181	2	clinical	clinical	ADJ
globalce-157	181	3	engineering	engineering	PROPN
globalce-157	181	4	vol.6	vol.6	PROPN
globalce-157	181	5	issue	issue	NOUN
globalce-157	181	6	1	1	NUM
globalce-157	181	7	:	:	SYM
globalce-157	181	8	2023	2023	NUM
globalce-157	181	9	14	14	NUM
globalce-157	181	10	discussion	discussion	NOUN
globalce-157	181	11	there	there	PRON
globalce-157	181	12	has	have	AUX
globalce-157	181	13	been	be	AUX
globalce-157	181	14	an	an	DET
globalce-157	181	15	obvious	obvious	ADJ
globalce-157	181	16	increase	increase	NOUN
globalce-157	181	17	in	in	ADP
globalce-157	181	18	the	the	DET
globalce-157	181	19	number	number	NOUN
globalce-157	181	20	of	of	ADP
globalce-157	181	21	reports	report	NOUN
globalce-157	181	22	over	over	ADP
globalce-157	181	23	the	the	DET
globalce-157	181	24	last	last	ADJ
globalce-157	181	25	years	year	NOUN
globalce-157	181	26	(	(	PUNCT
globalce-157	181	27	see	see	VERB
globalce-157	181	28	figure	figure	NOUN
globalce-157	181	29	1	1	NUM
globalce-157	181	30	)	)	PUNCT
globalce-157	181	31	,	,	PUNCT
globalce-157	181	32	which	which	PRON
globalce-157	181	33	can	can	AUX
globalce-157	181	34	be	be	AUX
globalce-157	181	35	attributed	attribute	VERB
globalce-157	181	36	to	to	ADP
globalce-157	181	37	several	several	ADJ
globalce-157	181	38	factors	factor	NOUN
globalce-157	181	39	.	.	PUNCT
globalce-157	182	1	one	one	NUM
globalce-157	182	2	reason	reason	NOUN
globalce-157	182	3	is	be	AUX
globalce-157	182	4	the	the	DET
globalce-157	182	5	increased	increase	VERB
globalce-157	182	6	awareness	awareness	NOUN
globalce-157	182	7	and	and	CCONJ
globalce-157	182	8	reporting	reporting	NOUN
globalce-157	182	9	of	of	ADP
globalce-157	182	10	adverse	adverse	ADJ
globalce-157	182	11	events	event	NOUN
globalce-157	182	12	by	by	ADP
globalce-157	182	13	healthcare	healthcare	NOUN
globalce-157	182	14	professionals	professional	NOUN
globalce-157	182	15	and	and	CCONJ
globalce-157	182	16	patients	patient	NOUN
globalce-157	182	17	due	due	ADJ
globalce-157	182	18	to	to	ADP
globalce-157	182	19	improved	improve	VERB
globalce-157	182	20	access	access	NOUN
globalce-157	182	21	to	to	ADP
globalce-157	182	22	information	information	NOUN
globalce-157	182	23	and	and	CCONJ
globalce-157	182	24	reporting	reporting	NOUN
globalce-157	182	25	systems	system	NOUN
globalce-157	182	26	.	.	PUNCT
globalce-157	183	1	another	another	DET
globalce-157	183	2	reason	reason	NOUN
globalce-157	183	3	is	be	AUX
globalce-157	183	4	the	the	DET
globalce-157	183	5	growing	grow	VERB
globalce-157	183	6	number	number	NOUN
globalce-157	183	7	and	and	CCONJ
globalce-157	183	8	complexity	complexity	NOUN
globalce-157	183	9	of	of	ADP
globalce-157	183	10	mds	mds	PROPN
globalce-157	183	11	,	,	PUNCT
globalce-157	183	12	which	which	PRON
globalce-157	183	13	increases	increase	VERB
globalce-157	183	14	the	the	DET
globalce-157	183	15	likelihood	likelihood	NOUN
globalce-157	183	16	of	of	ADP
globalce-157	183	17	adverse	adverse	ADJ
globalce-157	183	18	events	event	NOUN
globalce-157	183	19	.	.	PUNCT
globalce-157	184	1	in	in	ADP
globalce-157	184	2	addition	addition	NOUN
globalce-157	184	3	,	,	PUNCT
globalce-157	184	4	the	the	DET
globalce-157	184	5	fda	fda	PROPN
globalce-157	184	6	has	have	AUX
globalce-157	184	7	expanded	expand	VERB
globalce-157	184	8	the	the	DET
globalce-157	184	9	types	type	NOUN
globalce-157	184	10	of	of	ADP
globalce-157	184	11	adverse	adverse	ADJ
globalce-157	184	12	events	event	NOUN
globalce-157	184	13	that	that	PRON
globalce-157	184	14	must	must	AUX
globalce-157	184	15	be	be	AUX
globalce-157	184	16	reported	report	VERB
globalce-157	184	17	by	by	ADP
globalce-157	184	18	manufacturers	manufacturer	NOUN
globalce-157	184	19	and	and	CCONJ
globalce-157	184	20	healthcare	healthcare	PROPN
globalce-157	184	21	facilities	facility	NOUN
globalce-157	184	22	,	,	PUNCT
globalce-157	184	23	which	which	PRON
globalce-157	184	24	has	have	AUX
globalce-157	184	25	led	lead	VERB
globalce-157	184	26	to	to	ADP
globalce-157	184	27	an	an	DET
globalce-157	184	28	increase	increase	NOUN
globalce-157	184	29	in	in	ADP
globalce-157	184	30	the	the	DET
globalce-157	184	31	number	number	NOUN
globalce-157	184	32	of	of	ADP
globalce-157	184	33	reports	report	NOUN
globalce-157	184	34	submitted	submit	VERB
globalce-157	184	35	to	to	ADP
globalce-157	184	36	maude	maude	PROPN
globalce-157	184	37	.	.	PUNCT
globalce-157	185	1	other	other	ADJ
globalce-157	185	2	changes	change	NOUN
globalce-157	185	3	included	include	VERB
globalce-157	185	4	updated	update	VERB
globalce-157	185	5	reporting	reporting	NOUN
globalce-157	185	6	requirements	requirement	NOUN
globalce-157	185	7	for	for	ADP
globalce-157	185	8	specific	specific	ADJ
globalce-157	185	9	devices	device	NOUN
globalce-157	185	10	and	and	CCONJ
globalce-157	185	11	improved	improve	VERB
globalce-157	185	12	clarity	clarity	NOUN
globalce-157	185	13	on	on	ADP
globalce-157	185	14	using	use	VERB
globalce-157	185	15	the	the	DET
globalce-157	185	16	fda	fda	PROPN
globalce-157	185	17	forms	form	NOUN
globalce-157	185	18	3500/	3500/	NUM
globalce-157	185	19	3500a	3500a	NUM
globalce-157	185	20	for	for	ADP
globalce-157	185	21	reporting	report	VERB
globalce-157	185	22	.	.	PUNCT
globalce-157	186	1	these	these	DET
globalce-157	186	2	requirements	requirement	NOUN
globalce-157	186	3	are	be	AUX
globalce-157	186	4	outlined	outline	VERB
globalce-157	186	5	in	in	ADP
globalce-157	186	6	the	the	DET
globalce-157	186	7	code	code	NOUN
globalce-157	186	8	of	of	ADP
globalce-157	186	9	federal	federal	ADJ
globalce-157	186	10	regulations	regulation	NOUN
globalce-157	186	11	(	(	PUNCT
globalce-157	186	12	cfr	cfr	NOUN
globalce-157	186	13	)	)	PUNCT
globalce-157	186	14	title	title	NOUN
globalce-157	186	15	21	21	NUM
globalce-157	186	16	,	,	PUNCT
globalce-157	186	17	part	part	NOUN
globalce-157	186	18	803,(f	803,(f	NUM
globalce-157	186	19	)	)	PUNCT
globalce-157	186	20	which	which	PRON
globalce-157	186	21	establishes	establish	VERB
globalce-157	186	22	the	the	DET
globalce-157	186	23	mandatory	mandatory	ADJ
globalce-157	186	24	medical	medical	ADJ
globalce-157	186	25	device	device	NOUN
globalce-157	186	26	reporting	reporting	NOUN
globalce-157	186	27	criteria	criterion	NOUN
globalce-157	186	28	.	.	PUNCT
globalce-157	187	1	this	this	DET
globalce-157	187	2	rule	rule	NOUN
globalce-157	187	3	was	be	AUX
globalce-157	187	4	published	publish	VERB
globalce-157	187	5	in	in	ADP
globalce-157	187	6	2014	2014	NUM
globalce-157	187	7	and	and	CCONJ
globalce-157	187	8	implemented	implement	VERB
globalce-157	187	9	in	in	ADP
globalce-157	187	10	2015	2015	NUM
globalce-157	187	11	.	.	PUNCT
globalce-157	188	1	under	under	ADP
globalce-157	188	2	its	its	PRON
globalce-157	188	3	requirements	requirement	NOUN
globalce-157	188	4	,	,	PUNCT
globalce-157	188	5	manufacturers	manufacturer	NOUN
globalce-157	188	6	and	and	CCONJ
globalce-157	188	7	importers	importer	NOUN
globalce-157	188	8	of	of	ADP
globalce-157	188	9	mds	mds	PROPN
globalce-157	188	10	are	be	AUX
globalce-157	188	11	required	require	VERB
globalce-157	188	12	to	to	PART
globalce-157	188	13	report	report	VERB
globalce-157	188	14	to	to	ADP
globalce-157	188	15	the	the	DET
globalce-157	188	16	fda	fda	PROPN
globalce-157	188	17	any	any	DET
globalce-157	188	18	serious	serious	ADJ
globalce-157	188	19	injuries	injury	NOUN
globalce-157	188	20	or	or	CCONJ
globalce-157	188	21	deaths	death	NOUN
globalce-157	188	22	associated	associate	VERB
globalce-157	188	23	with	with	ADP
globalce-157	188	24	their	their	PRON
globalce-157	188	25	devices	device	NOUN
globalce-157	188	26	within	within	ADP
globalce-157	188	27	30	30	NUM
globalce-157	188	28	calendar	calendar	NOUN
globalce-157	188	29	days	day	NOUN
globalce-157	188	30	of	of	ADP
globalce-157	188	31	becoming	become	VERB
globalce-157	188	32	aware	aware	ADJ
globalce-157	188	33	of	of	ADP
globalce-157	188	34	the	the	DET
globalce-157	188	35	incident	incident	NOUN
globalce-157	188	36	.	.	PUNCT
globalce-157	189	1	additionally	additionally	ADV
globalce-157	189	2	,	,	PUNCT
globalce-157	189	3	manufacturers	manufacturer	NOUN
globalce-157	189	4	must	must	AUX
globalce-157	189	5	report	report	VERB
globalce-157	189	6	any	any	DET
globalce-157	189	7	malfunctions	malfunction	NOUN
globalce-157	189	8	that	that	PRON
globalce-157	189	9	could	could	AUX
globalce-157	189	10	result	result	VERB
globalce-157	189	11	in	in	ADP
globalce-157	189	12	a	a	DET
globalce-157	189	13	serious	serious	ADJ
globalce-157	189	14	injury	injury	NOUN
globalce-157	189	15	or	or	CCONJ
globalce-157	189	16	death	death	NOUN
globalce-157	189	17	within	within	ADP
globalce-157	189	18	5	5	NUM
globalce-157	189	19	workdays	workday	NOUN
globalce-157	189	20	of	of	ADP
globalce-157	189	21	becoming	become	VERB
globalce-157	189	22	aware	aware	ADJ
globalce-157	189	23	of	of	ADP
globalce-157	189	24	the	the	DET
globalce-157	189	25	issue	issue	NOUN
globalce-157	189	26	.	.	PUNCT
globalce-157	190	1	moreover	moreover	ADV
globalce-157	190	2	,	,	PUNCT
globalce-157	190	3	healthcare	healthcare	NOUN
globalce-157	190	4	facilities	facility	NOUN
globalce-157	190	5	,	,	PUNCT
globalce-157	190	6	such	such	ADJ
globalce-157	190	7	as	as	ADP
globalce-157	190	8	hospitals	hospital	NOUN
globalce-157	190	9	,	,	PUNCT
globalce-157	190	10	nursing	nursing	NOUN
globalce-157	190	11	homes	home	NOUN
globalce-157	190	12	,	,	PUNCT
globalce-157	190	13	and	and	CCONJ
globalce-157	190	14	outpatient	outpatient	NOUN
globalce-157	190	15	clinics	clinic	NOUN
globalce-157	190	16	,	,	PUNCT
globalce-157	190	17	must	must	AUX
globalce-157	190	18	report	report	VERB
globalce-157	190	19	certain	certain	ADJ
globalce-157	190	20	adverse	adverse	ADJ
globalce-157	190	21	events	event	NOUN
globalce-157	190	22	related	relate	VERB
globalce-157	190	23	to	to	ADP
globalce-157	190	24	mds	mds	NOUN
globalce-157	190	25	to	to	ADP
globalce-157	190	26	the	the	DET
globalce-157	190	27	fda	fda	PROPN
globalce-157	190	28	within	within	ADP
globalce-157	190	29	10	10	NUM
globalce-157	190	30	days	day	NOUN
globalce-157	190	31	.	.	PUNCT
globalce-157	191	1	these	these	DET
globalce-157	191	2	events	event	NOUN
globalce-157	191	3	include	include	VERB
globalce-157	191	4	incidents	incident	NOUN
globalce-157	191	5	that	that	PRON
globalce-157	191	6	result	result	VERB
globalce-157	191	7	in	in	ADP
globalce-157	191	8	serious	serious	ADJ
globalce-157	191	9	injury	injury	NOUN
globalce-157	191	10	or	or	CCONJ
globalce-157	191	11	death	death	NOUN
globalce-157	191	12	or	or	CCONJ
globalce-157	191	13	require	require	VERB
globalce-157	191	14	intervention	intervention	NOUN
globalce-157	191	15	to	to	PART
globalce-157	191	16	prevent	prevent	VERB
globalce-157	191	17	serious	serious	ADJ
globalce-157	191	18	injury	injury	NOUN
globalce-157	191	19	or	or	CCONJ
globalce-157	191	20	death	death	NOUN
globalce-157	191	21	.	.	PUNCT
globalce-157	192	1	finally	finally	ADV
globalce-157	192	2	,	,	PUNCT
globalce-157	192	3	in	in	ADP
globalce-157	192	4	2014	2014	NUM
globalce-157	192	5	,	,	PUNCT
globalce-157	192	6	the	the	DET
globalce-157	192	7	fda	fda	PROPN
globalce-157	192	8	published	publish	VERB
globalce-157	192	9	a	a	DET
globalce-157	192	10	final	final	ADJ
globalce-157	192	11	rule	rule	NOUN
globalce-157	192	12	on	on	ADP
globalce-157	192	13	electronic	electronic	ADJ
globalce-157	192	14	medical	medical	ADJ
globalce-157	192	15	device	device	NOUN
globalce-157	192	16	reporting	reporting	NOUN
globalce-157	192	17	(	(	PUNCT
globalce-157	192	18	emdr	emdr	ADJ
globalce-157	192	19	)	)	PUNCT
globalce-157	192	20	,	,	PUNCT
globalce-157	192	21	effective	effective	ADJ
globalce-157	192	22	from	from	ADP
globalce-157	192	23	2015	2015	NUM
globalce-157	192	24	,	,	PUNCT
globalce-157	192	25	that	that	PRON
globalce-157	192	26	requires	require	VERB
globalce-157	192	27	manufacturers	manufacturer	NOUN
globalce-157	192	28	and	and	CCONJ
globalce-157	192	29	importers	importer	NOUN
globalce-157	192	30	to	to	PART
globalce-157	192	31	submit	submit	VERB
globalce-157	192	32	mdrs	mdrs	PROPN
globalce-157	192	33	to	to	ADP
globalce-157	192	34	the	the	DET
globalce-157	192	35	fda	fda	PROPN
globalce-157	192	36	in	in	ADP
globalce-157	192	37	an	an	DET
globalce-157	192	38	electronic	electronic	ADJ
globalce-157	192	39	format	format	NOUN
globalce-157	192	40	that	that	PRON
globalce-157	192	41	the	the	DET
globalce-157	192	42	fda	fda	PROPN
globalce-157	192	43	can	can	AUX
globalce-157	192	44	process	process	VERB
globalce-157	192	45	,	,	PUNCT
globalce-157	192	46	review	review	NOUN
globalce-157	192	47	,	,	PUNCT
globalce-157	192	48	and	and	CCONJ
globalce-157	192	49	archive(20	archive(20	NOUN
globalce-157	192	50	)	)	PUNCT
globalce-157	192	51	.	.	PUNCT
globalce-157	193	1	last	last	ADJ
globalce-157	193	2	but	but	CCONJ
globalce-157	193	3	not	not	PART
globalce-157	193	4	least	least	ADJ
globalce-157	193	5	,	,	PUNCT
globalce-157	193	6	in	in	ADP
globalce-157	193	7	the	the	DET
globalce-157	193	8	previous	previous	ADJ
globalce-157	193	9	two	two	NUM
globalce-157	193	10	decades	decade	NOUN
globalce-157	193	11	,	,	PUNCT
globalce-157	193	12	there	there	PRON
globalce-157	193	13	has	have	AUX
globalce-157	193	14	been	be	AUX
globalce-157	193	15	observed	observe	VERB
globalce-157	193	16	an	an	DET
globalce-157	193	17	increasing	increase	VERB
globalce-157	193	18	number	number	NOUN
globalce-157	193	19	of	of	ADP
globalce-157	193	20	mds	mds	NOUN
globalce-157	193	21	that	that	PRON
globalce-157	193	22	have	have	AUX
globalce-157	193	23	received	receive	VERB
globalce-157	193	24	a	a	DET
globalce-157	193	25	510(k	510(k	PROPN
globalce-157	193	26	)	)	PUNCT
globalce-157	193	27	clearance	clearance	NOUN
globalce-157	193	28	compared	compare	VERB
globalce-157	193	29	to	to	ADP
globalce-157	193	30	a	a	DET
globalce-157	193	31	premarket	premarket	NOUN
globalce-157	193	32	approval	approval	NOUN
globalce-157	193	33	(	(	PUNCT
globalce-157	193	34	pma	pma	NOUN
globalce-157	193	35	)	)	PUNCT
globalce-157	193	36	.	.	PUNCT
globalce-157	194	1	safety	safety	NOUN
globalce-157	194	2	issues	issue	NOUN
globalce-157	194	3	are	be	AUX
globalce-157	194	4	raised	raise	VERB
globalce-157	194	5	as	as	SCONJ
globalce-157	194	6	the	the	DET
globalce-157	194	7	clearance	clearance	NOUN
globalce-157	194	8	provision	provision	NOUN
globalce-157	194	9	pathway	pathway	NOUN
globalce-157	194	10	does	do	AUX
globalce-157	194	11	not	not	PART
globalce-157	194	12	require	require	VERB
globalce-157	194	13	clinical	clinical	ADJ
globalce-157	194	14	trials	trial	NOUN
globalce-157	194	15	and	and	CCONJ
globalce-157	194	16	is	be	AUX
globalce-157	194	17	less	less	ADV
globalce-157	194	18	rigorous	rigorous	ADJ
globalce-157	194	19	than	than	ADP
globalce-157	194	20	the	the	DET
globalce-157	194	21	pma	pma	NOUN
globalce-157	194	22	process	process	NOUN
globalce-157	194	23	(	(	PUNCT
globalce-157	194	24	21,22	21,22	NOUN
globalce-157	194	25	)	)	PUNCT
globalce-157	194	26	.	.	PUNCT
globalce-157	195	1	considering	consider	VERB
globalce-157	195	2	the	the	DET
globalce-157	195	3	number	number	NOUN
globalce-157	195	4	of	of	ADP
globalce-157	195	5	total	total	ADJ
globalce-157	195	6	reports	report	NOUN
globalce-157	195	7	in	in	ADP
globalce-157	195	8	maude	maude	PROPN
globalce-157	195	9	and	and	CCONJ
globalce-157	195	10	the	the	DET
globalce-157	195	11	death	death	NOUN
globalce-157	195	12	event	event	NOUN
globalce-157	195	13	type	type	NOUN
globalce-157	195	14	percentage	percentage	NOUN
globalce-157	195	15	of	of	ADP
globalce-157	195	16	these	these	DET
globalce-157	195	17	reports	report	NOUN
globalce-157	195	18	presented	present	VERB
globalce-157	195	19	in	in	ADP
globalce-157	195	20	table	table	NOUN
globalce-157	195	21	2	2	NUM
globalce-157	195	22	,	,	PUNCT
globalce-157	195	23	it	it	PRON
globalce-157	195	24	means	mean	VERB
globalce-157	195	25	that	that	SCONJ
globalce-157	195	26	more	more	ADJ
globalce-157	195	27	than	than	ADP
globalce-157	195	28	180,000	180,000	NUM
globalce-157	195	29	adverse	adverse	ADJ
globalce-157	195	30	events	event	NOUN
globalce-157	195	31	are	be	AUX
globalce-157	195	32	historically	historically	ADV
globalce-157	195	33	related	relate	VERB
globalce-157	195	34	to	to	ADP
globalce-157	195	35	patient	patient	ADJ
globalce-157	195	36	death	death	NOUN
globalce-157	195	37	.	.	PUNCT
globalce-157	196	1	however	however	ADV
globalce-157	196	2	,	,	PUNCT
globalce-157	196	3	this	this	DET
globalce-157	196	4	number	number	NOUN
globalce-157	196	5	can	can	AUX
globalce-157	196	6	be	be	AUX
globalce-157	196	7	used	use	VERB
globalce-157	196	8	only	only	ADV
globalce-157	196	9	as	as	ADP
globalce-157	196	10	an	an	DET
globalce-157	196	11	approximation	approximation	NOUN
globalce-157	196	12	due	due	ADP
globalce-157	196	13	to	to	ADP
globalce-157	196	14	the	the	DET
globalce-157	196	15	limitations	limitation	NOUN
globalce-157	196	16	of	of	ADP
globalce-157	196	17	the	the	DET
globalce-157	196	18	database	database	NOUN
globalce-157	196	19	(	(	PUNCT
globalce-157	196	20	i.e.	i.e.	X
globalce-157	196	21	,	,	PUNCT
globalce-157	196	22	multiple	multiple	ADJ
globalce-157	196	23	reports	report	NOUN
globalce-157	196	24	on	on	ADP
globalce-157	196	25	the	the	DET
globalce-157	196	26	same	same	ADJ
globalce-157	196	27	incident	incident	NOUN
globalce-157	196	28	,	,	PUNCT
globalce-157	196	29	underreporting	underreporting	NOUN
globalce-157	196	30	,	,	PUNCT
globalce-157	196	31	incomplete	incomplete	ADJ
globalce-157	196	32	figure	figure	NOUN
globalce-157	196	33	8	8	NUM
globalce-157	196	34	.	.	PUNCT
globalce-157	196	35	device	device	NOUN
globalce-157	196	36	age	age	NOUN
globalce-157	196	37	distribution	distribution	NOUN
globalce-157	196	38	.	.	PUNCT
globalce-157	197	1	annual	annual	ADJ
globalce-157	197	2	mean	mean	ADJ
globalce-157	197	3	age	age	NOUN
globalce-157	197	4	of	of	ADP
globalce-157	197	5	reported	report	VERB
globalce-157	197	6	devices	device	NOUN
globalce-157	197	7	(	(	PUNCT
globalce-157	197	8	top	top	NOUN
globalce-157	197	9	)	)	PUNCT
globalce-157	197	10	and	and	CCONJ
globalce-157	197	11	total	total	ADJ
globalce-157	197	12	device	device	NOUN
globalce-157	197	13	age	age	NOUN
globalce-157	197	14	histogram	histogram	NOUN
globalce-157	197	15	(	(	PUNCT
globalce-157	197	16	bottom	bottom	NOUN
globalce-157	197	17	)	)	PUNCT
globalce-157	197	18	.	.	PUNCT
globalce-157	198	1	f	f	PROPN
globalce-157	198	2	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803	PROPN
globalce-157	198	3	.	.	PUNCT
globalce-157	199	1	medical	medical	ADJ
globalce-157	199	2	device	device	NOUN
globalce-157	199	3	reporting	reporting	NOUN
globalce-157	199	4	:	:	PUNCT
globalce-157	199	5	electronic	electronic	ADJ
globalce-157	199	6	submission	submission	NOUN
globalce-157	199	7	requirements	requirement	NOUN
globalce-157	199	8	.	.	PUNCT
globalce-157	200	1	a	a	DET
globalce-157	200	2	rule	rule	NOUN
globalce-157	200	3	by	by	ADP
globalce-157	200	4	the	the	DET
globalce-157	200	5	health	health	PROPN
globalce-157	200	6	and	and	CCONJ
globalce-157	200	7	human	human	PROPN
globalce-157	200	8	services	services	PROPN
globalce-157	200	9	department	department	NOUN
globalce-157	200	10	,	,	PUNCT
globalce-157	200	11	and	and	CCONJ
globalce-157	200	12	the	the	DET
globalce-157	200	13	food	food	NOUN
globalce-157	200	14	and	and	CCONJ
globalce-157	200	15	drug	drug	NOUN
globalce-157	200	16	administration	administration	NOUN
globalce-157	200	17	.	.	PUNCT
globalce-157	201	1	published	publish	VERB
globalce-157	201	2	2014	2014	NUM
globalce-157	201	3	.	.	PUNCT
globalce-157	202	1	effective	effective	ADJ
globalce-157	202	2	after	after	ADP
globalce-157	202	3	2015	2015	NUM
globalce-157	202	4	.	.	PUNCT
globalce-157	203	1	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803	https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803	NOUN
globalce-157	203	2	15	15	NUM
globalce-157	203	3	j	j	PROPN
globalce-157	203	4	global	global	ADJ
globalce-157	203	5	clinical	clinical	ADJ
globalce-157	203	6	engineering	engineering	PROPN
globalce-157	203	7	vol.6	vol.6	PROPN
globalce-157	203	8	issue	issue	NOUN
globalce-157	203	9	1	1	NUM
globalce-157	203	10	:	:	SYM
globalce-157	203	11	2023	2023	NUM
globalce-157	203	12	zisimopoulos	zisimopoulo	NOUN
globalce-157	203	13	,	,	PUNCT
globalce-157	203	14	pallikarakis	pallikarakis	PROPN
globalce-157	203	15	:	:	PUNCT
globalce-157	203	16	an	an	DET
globalce-157	203	17	analysis	analysis	NOUN
globalce-157	203	18	of	of	ADP
globalce-157	203	19	adverse	adverse	ADJ
globalce-157	203	20	event	event	NOUN
globalce-157	203	21	reports	report	NOUN
globalce-157	203	22	in	in	ADP
globalce-157	203	23	fda	fda	PROPN
globalce-157	203	24	’s	’s	PART
globalce-157	203	25	maude	maude	PROPN
globalce-157	203	26	database	database	PROPN
globalce-157	203	27	information	information	PROPN
globalce-157	203	28	,	,	PUNCT
globalce-157	203	29	etc	etc	X
globalce-157	203	30	.	.	X
globalce-157	203	31	)	)	PUNCT
globalce-157	203	32	.	.	PUNCT
globalce-157	204	1	although	although	SCONJ
globalce-157	204	2	the	the	DET
globalce-157	204	3	decrease	decrease	NOUN
globalce-157	204	4	in	in	ADP
globalce-157	204	5	deaths	death	NOUN
globalce-157	204	6	and	and	CCONJ
globalce-157	204	7	increase	increase	VERB
globalce-157	204	8	in	in	ADP
globalce-157	204	9	malfunctions	malfunction	NOUN
globalce-157	204	10	reported	report	VERB
globalce-157	204	11	in	in	ADP
globalce-157	204	12	figure	figure	NOUN
globalce-157	204	13	3	3	NUM
globalce-157	204	14	,	,	PUNCT
globalce-157	204	15	although	although	SCONJ
globalce-157	204	16	possible	possible	ADJ
globalce-157	204	17	,	,	PUNCT
globalce-157	204	18	does	do	AUX
globalce-157	204	19	not	not	PART
globalce-157	204	20	explicitly	explicitly	ADV
globalce-157	204	21	indicate	indicate	VERB
globalce-157	204	22	an	an	DET
globalce-157	204	23	increase	increase	NOUN
globalce-157	204	24	in	in	ADP
globalce-157	204	25	device	device	NOUN
globalce-157	204	26	safety	safety	NOUN
globalce-157	204	27	,	,	PUNCT
globalce-157	204	28	as	as	SCONJ
globalce-157	204	29	it	it	PRON
globalce-157	204	30	could	could	AUX
globalce-157	204	31	also	also	ADV
globalce-157	204	32	mean	mean	VERB
globalce-157	204	33	the	the	DET
globalce-157	204	34	intensified	intensified	ADJ
globalce-157	204	35	reporting	reporting	NOUN
globalce-157	204	36	of	of	ADP
globalce-157	204	37	less	less	ADV
globalce-157	204	38	severe	severe	ADJ
globalce-157	204	39	adverse	adverse	ADJ
globalce-157	204	40	events	event	NOUN
globalce-157	204	41	compared	compare	VERB
globalce-157	204	42	to	to	ADP
globalce-157	204	43	the	the	DET
globalce-157	204	44	past	past	ADJ
globalce-157	204	45	years	year	NOUN
globalce-157	204	46	.	.	PUNCT
globalce-157	205	1	some	some	DET
globalce-157	205	2	intuition	intuition	NOUN
globalce-157	205	3	can	can	AUX
globalce-157	205	4	be	be	AUX
globalce-157	205	5	gained	gain	VERB
globalce-157	205	6	about	about	ADP
globalce-157	205	7	the	the	DET
globalce-157	205	8	event	event	NOUN
globalce-157	205	9	types	type	NOUN
globalce-157	205	10	for	for	ADP
globalce-157	205	11	each	each	DET
globalce-157	205	12	examined	examine	VERB
globalce-157	205	13	device	device	NOUN
globalce-157	205	14	group	group	NOUN
globalce-157	205	15	.	.	PUNCT
globalce-157	206	1	glucose	glucose	NOUN
globalce-157	206	2	testing	testing	NOUN
globalce-157	206	3	devices	device	NOUN
globalce-157	206	4	,	,	PUNCT
globalce-157	206	5	such	such	ADJ
globalce-157	206	6	as	as	ADP
globalce-157	206	7	test	test	NOUN
globalce-157	206	8	strips	strip	NOUN
globalce-157	206	9	,	,	PUNCT
globalce-157	206	10	are	be	AUX
globalce-157	206	11	associated	associate	VERB
globalce-157	206	12	mainly	mainly	ADV
globalce-157	206	13	with	with	ADP
globalce-157	206	14	a	a	DET
globalce-157	206	15	less	less	ADV
globalce-157	206	16	serious	serious	ADJ
globalce-157	206	17	malfunction	malfunction	NOUN
globalce-157	206	18	(	(	PUNCT
globalce-157	206	19	see	see	VERB
globalce-157	206	20	table	table	NOUN
globalce-157	206	21	2	2	NUM
globalce-157	206	22	)	)	PUNCT
globalce-157	206	23	.	.	PUNCT
globalce-157	207	1	an	an	DET
globalce-157	207	2	example	example	NOUN
globalce-157	207	3	of	of	ADP
globalce-157	207	4	such	such	DET
globalce-157	207	5	a	a	DET
globalce-157	207	6	malfunction	malfunction	NOUN
globalce-157	207	7	could	could	AUX
globalce-157	207	8	be	be	AUX
globalce-157	207	9	wrong	wrong	ADJ
globalce-157	207	10	glucose	glucose	NOUN
globalce-157	207	11	test	test	NOUN
globalce-157	207	12	results	result	NOUN
globalce-157	207	13	.	.	PUNCT
globalce-157	208	1	although	although	SCONJ
globalce-157	208	2	not	not	PART
globalce-157	208	3	crucial	crucial	ADJ
globalce-157	208	4	as	as	ADP
globalce-157	208	5	an	an	DET
globalce-157	208	6	adverse	adverse	ADJ
globalce-157	208	7	event	event	NOUN
globalce-157	208	8	itself	itself	PRON
globalce-157	208	9	,	,	PUNCT
globalce-157	208	10	such	such	DET
globalce-157	208	11	a	a	DET
globalce-157	208	12	malfunction	malfunction	NOUN
globalce-157	208	13	could	could	AUX
globalce-157	208	14	pose	pose	VERB
globalce-157	208	15	more	more	ADV
globalce-157	208	16	serious	serious	ADJ
globalce-157	208	17	consequences	consequence	NOUN
globalce-157	208	18	for	for	ADP
globalce-157	208	19	the	the	DET
globalce-157	208	20	patient	patient	NOUN
globalce-157	208	21	in	in	ADP
globalce-157	208	22	the	the	DET
globalce-157	208	23	long	long	ADJ
globalce-157	208	24	term	term	NOUN
globalce-157	208	25	.	.	PUNCT
globalce-157	209	1	this	this	PRON
globalce-157	209	2	may	may	AUX
globalce-157	209	3	be	be	AUX
globalce-157	209	4	why	why	SCONJ
globalce-157	209	5	these	these	DET
globalce-157	209	6	devices	device	NOUN
globalce-157	209	7	have	have	VERB
globalce-157	209	8	a	a	DET
globalce-157	209	9	very	very	ADV
globalce-157	209	10	high	high	ADJ
globalce-157	209	11	rate	rate	NOUN
globalce-157	209	12	of	of	ADP
globalce-157	209	13	recalls	recall	NOUN
globalce-157	209	14	(	(	PUNCT
globalce-157	209	15	table	table	NOUN
globalce-157	209	16	3	3	NUM
globalce-157	209	17	)	)	PUNCT
globalce-157	209	18	.	.	PUNCT
globalce-157	210	1	in	in	ADP
globalce-157	210	2	contrast	contrast	NOUN
globalce-157	210	3	to	to	ADP
globalce-157	210	4	glucose	glucose	NOUN
globalce-157	210	5	testing	testing	NOUN
globalce-157	210	6	devices	device	NOUN
globalce-157	210	7	,	,	PUNCT
globalce-157	210	8	most	most	ADJ
globalce-157	210	9	of	of	ADP
globalce-157	210	10	the	the	DET
globalce-157	210	11	reported	report	VERB
globalce-157	210	12	incidents	incident	NOUN
globalce-157	210	13	of	of	ADP
globalce-157	210	14	hip	hip	NOUN
globalce-157	210	15	prostheses	prosthesis	NOUN
globalce-157	210	16	(	(	PUNCT
globalce-157	210	17	kwa	kwa	PROPN
globalce-157	210	18	)	)	PUNCT
globalce-157	210	19	resulted	result	VERB
globalce-157	210	20	in	in	ADP
globalce-157	210	21	serious	serious	ADJ
globalce-157	210	22	patient	patient	ADJ
globalce-157	210	23	injury	injury	NOUN
globalce-157	210	24	,	,	PUNCT
globalce-157	210	25	with	with	ADP
globalce-157	210	26	a	a	DET
globalce-157	210	27	probability	probability	NOUN
globalce-157	210	28	of	of	ADP
globalce-157	210	29	patients	patient	NOUN
globalce-157	210	30	having	have	VERB
globalce-157	210	31	to	to	PART
globalce-157	210	32	undergo	undergo	VERB
globalce-157	210	33	revision	revision	NOUN
globalce-157	210	34	surgery	surgery	NOUN
globalce-157	210	35	.	.	PUNCT
globalce-157	211	1	patient	patient	ADJ
globalce-157	211	2	injury	injury	NOUN
globalce-157	211	3	was	be	AUX
globalce-157	211	4	almost	almost	ADV
globalce-157	211	5	universal	universal	ADJ
globalce-157	211	6	(	(	PUNCT
globalce-157	211	7	98.4	98.4	NUM
globalce-157	211	8	%	%	NOUN
globalce-157	211	9	)	)	PUNCT
globalce-157	211	10	for	for	ADP
globalce-157	211	11	dental	dental	ADJ
globalce-157	211	12	implant	implant	ADJ
globalce-157	211	13	adverse	adverse	ADJ
globalce-157	211	14	events	event	NOUN
globalce-157	211	15	.	.	PUNCT
globalce-157	212	1	a	a	DET
globalce-157	212	2	factor	factor	NOUN
globalce-157	212	3	that	that	PRON
globalce-157	212	4	may	may	AUX
globalce-157	212	5	be	be	AUX
globalce-157	212	6	of	of	ADP
globalce-157	212	7	importance	importance	NOUN
globalce-157	212	8	is	be	AUX
globalce-157	212	9	the	the	DET
globalce-157	212	10	absence	absence	NOUN
globalce-157	212	11	of	of	ADP
globalce-157	212	12	implant	implant	ADJ
globalce-157	212	13	dentistry	dentistry	NOUN
globalce-157	212	14	from	from	ADP
globalce-157	212	15	the	the	DET
globalce-157	212	16	recognized	recognize	VERB
globalce-157	212	17	dental	dental	ADJ
globalce-157	212	18	specialties	specialty	NOUN
globalce-157	212	19	of	of	ADP
globalce-157	212	20	the	the	DET
globalce-157	212	21	american	american	ADJ
globalce-157	212	22	dental	dental	NOUN
globalce-157	212	23	association.(g	association.(g	PROPN
globalce-157	212	24	)	)	PUNCT
globalce-157	212	25	although	although	SCONJ
globalce-157	212	26	the	the	DET
globalce-157	212	27	fda	fda	PROPN
globalce-157	212	28	monitors	monitor	NOUN
globalce-157	212	29	and	and	CCONJ
globalce-157	212	30	regulates	regulate	VERB
globalce-157	212	31	mds	mds	PROPN
globalce-157	212	32	,	,	PUNCT
globalce-157	212	33	it	it	PRON
globalce-157	212	34	does	do	AUX
globalce-157	212	35	not	not	PART
globalce-157	212	36	act	act	VERB
globalce-157	212	37	toward	toward	ADP
globalce-157	212	38	healthcare	healthcare	NOUN
globalce-157	212	39	practice	practice	NOUN
globalce-157	212	40	regulations	regulation	NOUN
globalce-157	212	41	.	.	PUNCT
globalce-157	213	1	the	the	DET
globalce-157	213	2	fact	fact	NOUN
globalce-157	213	3	that	that	SCONJ
globalce-157	213	4	implantable	implantable	ADJ
globalce-157	213	5	defibrillators	defibrillator	NOUN
globalce-157	213	6	adverse	adverse	ADJ
globalce-157	213	7	events	event	NOUN
globalce-157	213	8	showcase	showcase	VERB
globalce-157	213	9	the	the	DET
globalce-157	213	10	highest	high	ADJ
globalce-157	213	11	probability	probability	NOUN
globalce-157	213	12	of	of	ADP
globalce-157	213	13	death	death	NOUN
globalce-157	213	14	(	(	PUNCT
globalce-157	213	15	3.2	3.2	NUM
globalce-157	213	16	%	%	NOUN
globalce-157	213	17	)	)	PUNCT
globalce-157	213	18	compared	compare	VERB
globalce-157	213	19	to	to	ADP
globalce-157	213	20	the	the	DET
globalce-157	213	21	rest	rest	NOUN
globalce-157	213	22	of	of	ADP
globalce-157	213	23	the	the	DET
globalce-157	213	24	examined	examine	VERB
globalce-157	213	25	device	device	NOUN
globalce-157	213	26	groups	group	NOUN
globalce-157	213	27	is	be	AUX
globalce-157	213	28	expected	expect	VERB
globalce-157	213	29	,	,	PUNCT
globalce-157	213	30	due	due	ADP
globalce-157	213	31	to	to	ADP
globalce-157	213	32	their	their	PRON
globalce-157	213	33	crucial	crucial	ADJ
globalce-157	213	34	role	role	NOUN
globalce-157	213	35	in	in	ADP
globalce-157	213	36	physiological	physiological	ADJ
globalce-157	213	37	heart	heart	NOUN
globalce-157	213	38	function	function	NOUN
globalce-157	213	39	.	.	PUNCT
globalce-157	214	1	finally	finally	ADV
globalce-157	214	2	,	,	PUNCT
globalce-157	214	3	the	the	DET
globalce-157	214	4	fact	fact	NOUN
globalce-157	214	5	that	that	SCONJ
globalce-157	214	6	almost	almost	ADV
globalce-157	214	7	all	all	DET
globalce-157	214	8	the	the	DET
globalce-157	214	9	reports	report	NOUN
globalce-157	214	10	regarding	regard	VERB
globalce-157	214	11	infusion	infusion	NOUN
globalce-157	214	12	pumps	pump	NOUN
globalce-157	214	13	were	be	AUX
globalce-157	214	14	about	about	ADP
globalce-157	214	15	simple	simple	ADJ
globalce-157	214	16	device	device	NOUN
globalce-157	214	17	malfunctions	malfunction	NOUN
globalce-157	214	18	,	,	PUNCT
globalce-157	214	19	without	without	ADP
globalce-157	214	20	further	further	ADJ
globalce-157	214	21	serious	serious	ADJ
globalce-157	214	22	implications	implication	NOUN
globalce-157	214	23	to	to	ADP
globalce-157	214	24	the	the	DET
globalce-157	214	25	patients	patient	NOUN
globalce-157	214	26	,	,	PUNCT
globalce-157	214	27	may	may	AUX
globalce-157	214	28	indicate	indicate	VERB
globalce-157	214	29	an	an	DET
globalce-157	214	30	increased	increase	VERB
globalce-157	214	31	awareness	awareness	NOUN
globalce-157	214	32	regarding	regard	VERB
globalce-157	214	33	adverse	adverse	ADJ
globalce-157	214	34	event	event	NOUN
globalce-157	214	35	reporting	reporting	NOUN
globalce-157	214	36	of	of	ADP
globalce-157	214	37	crucial	crucial	ADJ
globalce-157	214	38	devices	device	NOUN
globalce-157	214	39	.	.	PUNCT
globalce-157	215	1	however	however	ADV
globalce-157	215	2	,	,	PUNCT
globalce-157	215	3	it	it	PRON
globalce-157	215	4	should	should	AUX
globalce-157	215	5	be	be	AUX
globalce-157	215	6	noted	note	VERB
globalce-157	215	7	that	that	SCONJ
globalce-157	215	8	infusion	infusion	NOUN
globalce-157	215	9	pumps	pump	NOUN
globalce-157	215	10	malfunctions	malfunction	NOUN
globalce-157	215	11	have	have	VERB
globalce-157	215	12	a	a	DET
globalce-157	215	13	high	high	ADJ
globalce-157	215	14	potential	potential	NOUN
globalce-157	215	15	for	for	ADP
globalce-157	215	16	patient	patient	ADJ
globalce-157	215	17	injury	injury	NOUN
globalce-157	215	18	and	and	CCONJ
globalce-157	215	19	must	must	AUX
globalce-157	215	20	be	be	AUX
globalce-157	215	21	treated	treat	VERB
globalce-157	215	22	as	as	ADP
globalce-157	215	23	near	near	ADV
globalce-157	215	24	-	-	PUNCT
globalce-157	215	25	miss	miss	ADJ
globalce-157	215	26	adverse	adverse	ADJ
globalce-157	215	27	events	event	NOUN
globalce-157	215	28	.	.	PUNCT
globalce-157	216	1	these	these	DET
globalce-157	216	2	events	event	NOUN
globalce-157	216	3	are	be	AUX
globalce-157	216	4	incidents	incident	NOUN
globalce-157	216	5	that	that	PRON
globalce-157	216	6	can	can	AUX
globalce-157	216	7	potentially	potentially	ADV
globalce-157	216	8	cause	cause	VERB
globalce-157	216	9	harm	harm	NOUN
globalce-157	216	10	to	to	ADP
globalce-157	216	11	a	a	DET
globalce-157	216	12	patient	patient	NOUN
globalce-157	216	13	but	but	CCONJ
globalce-157	216	14	are	be	AUX
globalce-157	216	15	caught	catch	VERB
globalce-157	216	16	or	or	CCONJ
globalce-157	216	17	mitigated	mitigate	VERB
globalce-157	216	18	before	before	SCONJ
globalce-157	216	19	any	any	DET
globalce-157	216	20	actual	actual	ADJ
globalce-157	216	21	harm	harm	NOUN
globalce-157	216	22	occurs	occur	VERB
globalce-157	216	23	.	.	PUNCT
globalce-157	217	1	examples	example	NOUN
globalce-157	217	2	of	of	ADP
globalce-157	217	3	reported	report	VERB
globalce-157	217	4	infusion	infusion	NOUN
globalce-157	217	5	pump	pump	NOUN
globalce-157	217	6	problems	problem	NOUN
globalce-157	217	7	that	that	PRON
globalce-157	217	8	could	could	AUX
globalce-157	217	9	lead	lead	VERB
globalce-157	217	10	to	to	ADP
globalce-157	217	11	such	such	ADJ
globalce-157	217	12	incidents	incident	NOUN
globalce-157	217	13	include	include	VERB
globalce-157	217	14	lack	lack	NOUN
globalce-157	217	15	of	of	ADP
globalce-157	217	16	warning	warning	NOUN
globalce-157	217	17	when	when	SCONJ
globalce-157	217	18	inappropriate	inappropriate	ADJ
globalce-157	217	19	data	datum	NOUN
globalce-157	217	20	is	be	AUX
globalce-157	217	21	entered	enter	VERB
globalce-157	217	22	or	or	CCONJ
globalce-157	217	23	failure	failure	NOUN
globalce-157	217	24	to	to	PART
globalce-157	217	25	generate	generate	VERB
globalce-157	217	26	audible	audible	ADJ
globalce-157	217	27	alarms	alarm	NOUN
globalce-157	217	28	for	for	ADP
globalce-157	217	29	critical	critical	ADJ
globalce-157	217	30	problems	problem	NOUN
globalce-157	217	31	such	such	ADJ
globalce-157	217	32	as	as	ADP
globalce-157	217	33	an	an	DET
globalce-157	217	34	occlusion	occlusion	NOUN
globalce-157	217	35	in	in	ADP
globalce-157	217	36	the	the	DET
globalce-157	217	37	tubing.23	tubing.23	PROPN
globalce-157	217	38	and	and	CCONJ
globalce-157	217	39	adverse	adverse	ADJ
globalce-157	217	40	events	event	NOUN
globalce-157	217	41	are	be	AUX
globalce-157	217	42	often	often	ADV
globalce-157	217	43	avoided	avoid	VERB
globalce-157	217	44	due	due	ADP
globalce-157	217	45	to	to	ADP
globalce-157	217	46	luck	luck	NOUN
globalce-157	217	47	or	or	CCONJ
globalce-157	217	48	vigilant	vigilant	ADJ
globalce-157	217	49	healthcare	healthcare	NOUN
globalce-157	217	50	professionals	professional	NOUN
globalce-157	217	51	.	.	PUNCT
globalce-157	218	1	remedial	remedial	ADJ
globalce-157	218	2	action	action	NOUN
globalce-157	218	3	codes	code	NOUN
globalce-157	218	4	were	be	AUX
globalce-157	218	5	found	find	VERB
globalce-157	218	6	to	to	PART
globalce-157	218	7	be	be	AUX
globalce-157	218	8	often	often	ADV
globalce-157	218	9	omitted	omit	VERB
globalce-157	218	10	from	from	ADP
globalce-157	218	11	the	the	DET
globalce-157	218	12	adverse	adverse	ADJ
globalce-157	218	13	event	event	NOUN
globalce-157	218	14	reports	report	VERB
globalce-157	218	15	.	.	PUNCT
globalce-157	219	1	it	it	PRON
globalce-157	219	2	is	be	AUX
globalce-157	219	3	unclear	unclear	ADJ
globalce-157	219	4	whether	whether	SCONJ
globalce-157	219	5	this	this	PRON
globalce-157	219	6	is	be	AUX
globalce-157	219	7	because	because	SCONJ
globalce-157	219	8	the	the	DET
globalce-157	219	9	event	event	NOUN
globalce-157	219	10	resulted	result	VERB
globalce-157	219	11	in	in	ADP
globalce-157	219	12	no	no	DET
globalce-157	219	13	action	action	NOUN
globalce-157	219	14	to	to	PART
globalce-157	219	15	be	be	AUX
globalce-157	219	16	taken	take	VERB
globalce-157	219	17	by	by	ADP
globalce-157	219	18	the	the	DET
globalce-157	219	19	manufacturer	manufacturer	NOUN
globalce-157	219	20	or	or	CCONJ
globalce-157	219	21	the	the	DET
globalce-157	219	22	information	information	NOUN
globalce-157	219	23	was	be	AUX
globalce-157	219	24	not	not	PART
globalce-157	219	25	correctly	correctly	ADV
globalce-157	219	26	updated	update	VERB
globalce-157	219	27	in	in	ADP
globalce-157	219	28	the	the	DET
globalce-157	219	29	database	database	NOUN
globalce-157	219	30	.	.	PUNCT
globalce-157	220	1	as	as	ADP
globalce-157	220	2	a	a	DET
globalce-157	220	3	silver	silver	ADJ
globalce-157	220	4	lining	lining	NOUN
globalce-157	220	5	,	,	PUNCT
globalce-157	220	6	the	the	DET
globalce-157	220	7	rate	rate	NOUN
globalce-157	220	8	of	of	ADP
globalce-157	220	9	existing	exist	VERB
globalce-157	220	10	remedial	remedial	ADJ
globalce-157	220	11	actions	action	NOUN
globalce-157	220	12	has	have	AUX
globalce-157	220	13	risen	rise	VERB
globalce-157	220	14	in	in	ADP
globalce-157	220	15	the	the	DET
globalce-157	220	16	last	last	ADJ
globalce-157	220	17	year	year	NOUN
globalce-157	220	18	.	.	PUNCT
globalce-157	221	1	moreover	moreover	ADV
globalce-157	221	2	,	,	PUNCT
globalce-157	221	3	the	the	DET
globalce-157	221	4	“	"	PUNCT
globalce-157	221	5	other	other	ADJ
globalce-157	221	6	”	"	PUNCT
globalce-157	221	7	category	category	NOUN
globalce-157	221	8	is	be	AUX
globalce-157	221	9	used	use	VERB
globalce-157	221	10	less	less	ADV
globalce-157	221	11	frequently	frequently	ADV
globalce-157	221	12	,	,	PUNCT
globalce-157	221	13	which	which	PRON
globalce-157	221	14	may	may	AUX
globalce-157	221	15	indicate	indicate	VERB
globalce-157	221	16	that	that	SCONJ
globalce-157	221	17	the	the	DET
globalce-157	221	18	report	report	NOUN
globalce-157	221	19	form	form	NOUN
globalce-157	221	20	became	become	VERB
globalce-157	221	21	more	more	ADJ
globalce-157	221	22	user	user	NOUN
globalce-157	221	23	friendly	friendly	ADJ
globalce-157	221	24	and	and	CCONJ
globalce-157	221	25	awareness	awareness	NOUN
globalce-157	221	26	toward	toward	ADP
globalce-157	221	27	adverse	adverse	ADJ
globalce-157	221	28	event	event	NOUN
globalce-157	221	29	reporting	reporting	NOUN
globalce-157	221	30	has	have	AUX
globalce-157	221	31	risen	rise	VERB
globalce-157	221	32	.	.	PUNCT
globalce-157	222	1	the	the	DET
globalce-157	222	2	fact	fact	NOUN
globalce-157	222	3	that	that	SCONJ
globalce-157	222	4	the	the	DET
globalce-157	222	5	device	device	NOUN
globalce-157	222	6	manufacturers	manufacturer	NOUN
globalce-157	222	7	have	have	AUX
globalce-157	222	8	filed	file	VERB
globalce-157	222	9	96	96	NUM
globalce-157	222	10	%	%	NOUN
globalce-157	222	11	of	of	ADP
globalce-157	222	12	the	the	DET
globalce-157	222	13	reports	report	NOUN
globalce-157	222	14	,	,	PUNCT
globalce-157	222	15	while	while	SCONJ
globalce-157	222	16	the	the	DET
globalce-157	222	17	trend	trend	NOUN
globalce-157	222	18	is	be	AUX
globalce-157	222	19	continuously	continuously	ADV
globalce-157	222	20	rising	rise	VERB
globalce-157	222	21	(	(	PUNCT
globalce-157	222	22	figure	figure	NOUN
globalce-157	222	23	5	5	NUM
globalce-157	222	24	)	)	PUNCT
globalce-157	222	25	,	,	PUNCT
globalce-157	222	26	is	be	AUX
globalce-157	222	27	related	relate	VERB
globalce-157	222	28	to	to	ADP
globalce-157	222	29	the	the	DET
globalce-157	222	30	stricter	strict	ADJ
globalce-157	222	31	requirements	requirement	NOUN
globalce-157	222	32	imposed	impose	VERB
globalce-157	222	33	on	on	ADP
globalce-157	222	34	manufacturers	manufacturer	NOUN
globalce-157	222	35	by	by	ADP
globalce-157	222	36	cfr	cfr	PROPN
globalce-157	222	37	21	21	NUM
globalce-157	222	38	,	,	PUNCT
globalce-157	222	39	803	803	NUM
globalce-157	222	40	.	.	PUNCT
globalce-157	223	1	this	this	PRON
globalce-157	223	2	is	be	AUX
globalce-157	223	3	also	also	ADV
globalce-157	223	4	the	the	DET
globalce-157	223	5	reason	reason	NOUN
globalce-157	223	6	behind	behind	ADP
globalce-157	223	7	the	the	DET
globalce-157	223	8	high	high	ADJ
globalce-157	223	9	device	device	NOUN
globalce-157	223	10	evaluation	evaluation	NOUN
globalce-157	223	11	percentage	percentage	NOUN
globalce-157	223	12	by	by	ADP
globalce-157	223	13	the	the	DET
globalce-157	223	14	manufacturers	manufacturer	NOUN
globalce-157	223	15	(	(	PUNCT
globalce-157	223	16	figure	figure	NOUN
globalce-157	223	17	7	7	NUM
globalce-157	223	18	)	)	PUNCT
globalce-157	223	19	.	.	PUNCT
globalce-157	224	1	adding	add	VERB
globalce-157	224	2	to	to	ADP
globalce-157	224	3	this	this	PRON
globalce-157	224	4	,	,	PUNCT
globalce-157	224	5	many	many	ADJ
globalce-157	224	6	users	user	NOUN
globalce-157	224	7	from	from	ADP
globalce-157	224	8	facilities	facility	NOUN
globalce-157	224	9	or	or	CCONJ
globalce-157	224	10	homecare	homecare	NOUN
globalce-157	224	11	prefer	prefer	VERB
globalce-157	224	12	to	to	PART
globalce-157	224	13	file	file	VERB
globalce-157	224	14	a	a	DET
globalce-157	224	15	report	report	NOUN
globalce-157	224	16	to	to	ADP
globalce-157	224	17	the	the	DET
globalce-157	224	18	manufacturer	manufacturer	NOUN
globalce-157	224	19	,	,	PUNCT
globalce-157	224	20	who	who	PRON
globalce-157	224	21	then	then	ADV
globalce-157	224	22	submits	submit	VERB
globalce-157	224	23	it	it	PRON
globalce-157	224	24	to	to	ADP
globalce-157	224	25	fda	fda	PROPN
globalce-157	224	26	.	.	PUNCT
globalce-157	225	1	this	this	PRON
globalce-157	225	2	is	be	AUX
globalce-157	225	3	the	the	DET
globalce-157	225	4	reason	reason	NOUN
globalce-157	225	5	why	why	SCONJ
globalce-157	225	6	the	the	DET
globalce-157	225	7	initial	initial	ADJ
globalce-157	225	8	reporter	reporter	NOUN
globalce-157	225	9	occupation	occupation	NOUN
globalce-157	225	10	is	be	AUX
globalce-157	225	11	analyzed	analyze	VERB
globalce-157	225	12	separately	separately	ADV
globalce-157	225	13	.	.	PUNCT
globalce-157	226	1	data	datum	NOUN
globalce-157	226	2	for	for	ADP
globalce-157	226	3	1997	1997	NUM
globalce-157	226	4	consists	consist	VERB
globalce-157	226	5	of	of	ADP
globalce-157	226	6	all	all	DET
globalce-157	226	7	data	datum	NOUN
globalce-157	226	8	available	available	ADJ
globalce-157	226	9	from	from	ADP
globalce-157	226	10	1991	1991	NUM
globalce-157	226	11	to	to	ADP
globalce-157	226	12	that	that	DET
globalce-157	226	13	year	year	NOUN
globalce-157	226	14	.	.	PUNCT
globalce-157	227	1	according	accord	VERB
globalce-157	227	2	to	to	ADP
globalce-157	227	3	maude	maude	PROPN
globalce-157	227	4	,	,	PUNCT
globalce-157	227	5	user	user	NOUN
globalce-157	227	6	facility	facility	NOUN
globalce-157	227	7	reports	report	NOUN
globalce-157	227	8	have	have	AUX
globalce-157	227	9	been	be	AUX
globalce-157	227	10	submitted	submit	VERB
globalce-157	227	11	since	since	SCONJ
globalce-157	227	12	1991	1991	NUM
globalce-157	227	13	,	,	PUNCT
globalce-157	227	14	distributor	distributor	NOUN
globalce-157	227	15	and	and	CCONJ
globalce-157	227	16	voluntary	voluntary	ADJ
globalce-157	227	17	reports	report	NOUN
globalce-157	227	18	since	since	SCONJ
globalce-157	227	19	1993	1993	NUM
globalce-157	227	20	and	and	CCONJ
globalce-157	227	21	manufacturer	manufacturer	NOUN
globalce-157	227	22	reports	report	NOUN
globalce-157	227	23	since	since	SCONJ
globalce-157	227	24	1996	1996	NUM
globalce-157	227	25	.	.	PUNCT
globalce-157	228	1	for	for	ADP
globalce-157	228	2	this	this	DET
globalce-157	228	3	reason	reason	NOUN
globalce-157	228	4	,	,	PUNCT
globalce-157	228	5	the	the	DET
globalce-157	228	6	report	report	NOUN
globalce-157	228	7	rates	rate	NOUN
globalce-157	228	8	by	by	ADP
globalce-157	228	9	manufacturers	manufacturer	NOUN
globalce-157	228	10	are	be	AUX
globalce-157	228	11	quite	quite	ADV
globalce-157	228	12	low	low	ADJ
globalce-157	228	13	until	until	ADP
globalce-157	228	14	1996	1996	NUM
globalce-157	228	15	,	,	PUNCT
globalce-157	228	16	compared	compare	VERB
globalce-157	228	17	to	to	ADP
globalce-157	228	18	the	the	DET
globalce-157	228	19	next	next	ADJ
globalce-157	228	20	years	year	NOUN
globalce-157	228	21	.	.	PUNCT
globalce-157	229	1	according	accord	VERB
globalce-157	229	2	to	to	ADP
globalce-157	229	3	cfr	cfr	PROPN
globalce-157	229	4	21	21	NUM
globalce-157	229	5	,	,	PUNCT
globalce-157	229	6	803	803	NUM
globalce-157	229	7	,	,	PUNCT
globalce-157	229	8	§	§	NOUN
globalce-157	229	9	50	50	NUM
globalce-157	229	10	,	,	PUNCT
globalce-157	229	11	manufacturers	manufacturer	NOUN
globalce-157	229	12	are	be	AUX
globalce-157	229	13	responsible	responsible	ADJ
globalce-157	229	14	for	for	ADP
globalce-157	229	15	conducting	conduct	VERB
globalce-157	229	16	an	an	DET
globalce-157	229	17	investigation	investigation	NOUN
globalce-157	229	18	on	on	ADP
globalce-157	229	19	each	each	DET
globalce-157	229	20	event	event	NOUN
globalce-157	229	21	and	and	CCONJ
globalce-157	229	22	evaluating	evaluate	VERB
globalce-157	229	23	the	the	DET
globalce-157	229	24	cause	cause	NOUN
globalce-157	229	25	of	of	ADP
globalce-157	229	26	the	the	DET
globalce-157	229	27	event	event	NOUN
globalce-157	229	28	.	.	PUNCT
globalce-157	230	1	if	if	SCONJ
globalce-157	230	2	the	the	DET
globalce-157	230	3	device	device	NOUN
globalce-157	230	4	was	be	AUX
globalce-157	230	5	returned	return	VERB
globalce-157	230	6	to	to	ADP
globalce-157	230	7	them	they	PRON
globalce-157	230	8	and	and	CCONJ
globalce-157	230	9	information	information	NOUN
globalce-157	230	10	in	in	ADP
globalce-157	230	11	a	a	DET
globalce-157	230	12	report	report	NOUN
globalce-157	230	13	is	be	AUX
globalce-157	230	14	incomplete	incomplete	ADJ
globalce-157	230	15	,	,	PUNCT
globalce-157	230	16	they	they	PRON
globalce-157	230	17	must	must	AUX
globalce-157	230	18	explain	explain	VERB
globalce-157	230	19	why	why	SCONJ
globalce-157	230	20	and	and	CCONJ
globalce-157	230	21	the	the	DET
globalce-157	230	22	steps	step	NOUN
globalce-157	230	23	taken	take	VERB
globalce-157	230	24	to	to	PART
globalce-157	230	25	obtain	obtain	VERB
globalce-157	230	26	it	it	PRON
globalce-157	230	27	.	.	PUNCT
globalce-157	231	1	this	this	PRON
globalce-157	231	2	is	be	AUX
globalce-157	231	3	why	why	SCONJ
globalce-157	231	4	most	most	ADJ
globalce-157	231	5	devices	device	NOUN
globalce-157	231	6	returned	return	VERB
globalce-157	231	7	to	to	ADP
globalce-157	231	8	the	the	DET
globalce-157	231	9	manufacturer	manufacturer	NOUN
globalce-157	231	10	by	by	ADP
globalce-157	231	11	the	the	DET
globalce-157	231	12	user	user	NOUN
globalce-157	231	13	facility	facility	NOUN
globalce-157	231	14	or	or	CCONJ
globalce-157	231	15	the	the	DET
globalce-157	231	16	distributors	distributor	NOUN
globalce-157	231	17	are	be	AUX
globalce-157	231	18	evaluated	evaluate	VERB
globalce-157	231	19	(	(	PUNCT
globalce-157	231	20	70.8	70.8	NUM
globalce-157	231	21	%	%	NOUN
globalce-157	231	22	on	on	ADP
globalce-157	231	23	average	average	ADJ
globalce-157	231	24	)	)	PUNCT
globalce-157	231	25	.	.	PUNCT
globalce-157	232	1	the	the	DET
globalce-157	232	2	last	last	ADJ
globalce-157	232	3	year	year	NOUN
globalce-157	232	4	was	be	AUX
globalce-157	232	5	an	an	DET
globalce-157	232	6	exception	exception	NOUN
globalce-157	232	7	,	,	PUNCT
globalce-157	232	8	and	and	CCONJ
globalce-157	232	9	the	the	DET
globalce-157	232	10	reason	reason	NOUN
globalce-157	232	11	could	could	AUX
globalce-157	232	12	be	be	AUX
globalce-157	232	13	further	far	ADV
globalce-157	232	14	investigated	investigate	VERB
globalce-157	232	15	.	.	PUNCT
globalce-157	233	1	regarding	regard	VERB
globalce-157	233	2	the	the	DET
globalce-157	233	3	maude	maude	PROPN
globalce-157	233	4	database	database	NOUN
globalce-157	233	5	,	,	PUNCT
globalce-157	233	6	several	several	ADJ
globalce-157	233	7	issues	issue	NOUN
globalce-157	233	8	were	be	AUX
globalce-157	233	9	discovered	discover	VERB
globalce-157	233	10	.	.	PUNCT
globalce-157	234	1	first	first	ADV
globalce-157	234	2	,	,	PUNCT
globalce-157	234	3	there	there	PRON
globalce-157	234	4	are	be	VERB
globalce-157	234	5	some	some	DET
globalce-157	234	6	instances	instance	NOUN
globalce-157	234	7	of	of	ADP
globalce-157	234	8	unintuitive	unintuitive	ADJ
globalce-157	234	9	or	or	CCONJ
globalce-157	234	10	straight	straight	ADV
globalce-157	234	11	up	up	ADV
globalce-157	234	12	incorrect	incorrect	ADJ
globalce-157	234	13	information	information	NOUN
globalce-157	234	14	on	on	ADP
globalce-157	234	15	the	the	DET
globalce-157	234	16	use	use	NOUN
globalce-157	234	17	or	or	CCONJ
globalce-157	234	18	description	description	NOUN
globalce-157	234	19	of	of	ADP
globalce-157	234	20	the	the	DET
globalce-157	234	21	files	file	NOUN
globalce-157	234	22	.	.	PUNCT
globalce-157	235	1	as	as	ADP
globalce-157	235	2	an	an	DET
globalce-157	235	3	example	example	NOUN
globalce-157	235	4	,	,	PUNCT
globalce-157	235	5	the	the	DET
globalce-157	235	6	“	"	PUNCT
globalce-157	235	7	deviceproblemcodes	deviceproblemcodes	PROPN
globalce-157	235	8	”	"	PUNCT
globalce-157	235	9	file	file	NOUN
globalce-157	235	10	should	should	AUX
globalce-157	235	11	contain	contain	VERB
globalce-157	235	12	the	the	DET
globalce-157	235	13	mdr	mdr	PROPN
globalce-157	235	14	report	report	NOUN
globalce-157	235	15	keys	key	VERB
globalce-157	235	16	with	with	ADP
globalce-157	235	17	the	the	DET
globalce-157	235	18	corresponding	correspond	VERB
globalce-157	235	19	device	device	NOUN
globalce-157	235	20	problem	problem	NOUN
globalce-157	235	21	code	code	NOUN
globalce-157	235	22	,	,	PUNCT
globalce-157	235	23	while	while	SCONJ
globalce-157	235	24	the	the	DET
globalce-157	235	25	“	"	PUNCT
globalce-157	235	26	foidevproblem	foidevproblem	NOUN
globalce-157	235	27	”	"	PUNCT
globalce-157	235	28	file	file	NOUN
globalce-157	235	29	should	should	AUX
globalce-157	235	30	contain	contain	VERB
globalce-157	235	31	a	a	DET
globalce-157	235	32	list	list	NOUN
globalce-157	235	33	of	of	ADP
globalce-157	235	34	device	device	NOUN
globalce-157	235	35	problem	problem	NOUN
globalce-157	235	36	codes	code	NOUN
globalce-157	235	37	with	with	ADP
globalce-157	235	38	their	their	PRON
globalce-157	235	39	matching	match	VERB
globalce-157	235	40	code	code	NOUN
globalce-157	235	41	description	description	NOUN
globalce-157	235	42	,	,	PUNCT
globalce-157	235	43	according	accord	VERB
globalce-157	235	44	to	to	ADP
globalce-157	235	45	the	the	DET
globalce-157	235	46	site	site	NOUN
globalce-157	235	47	’s	’s	PART
globalce-157	235	48	g	g	PROPN
globalce-157	235	49	https://ncrdscb.ada.org/recognized-dental-specialties	https://ncrdscb.ada.org/recognized-dental-specialties	PROPN
globalce-157	235	50	https://ncrdscb.ada.org/recognized-dental-specialties	https://ncrdscb.ada.org/recognized-dental-specialties	PROPN
globalce-157	235	51	zisimopoulos	zisimopoulo	NOUN
globalce-157	235	52	,	,	PUNCT
globalce-157	235	53	pallikarakis	pallikarakis	PROPN
globalce-157	235	54	:	:	PUNCT
globalce-157	235	55	an	an	DET
globalce-157	235	56	analysis	analysis	NOUN
globalce-157	235	57	of	of	ADP
globalce-157	235	58	adverse	adverse	ADJ
globalce-157	235	59	event	event	NOUN
globalce-157	235	60	reports	report	NOUN
globalce-157	235	61	in	in	ADP
globalce-157	235	62	fda	fda	PROPN
globalce-157	235	63	’s	’s	PART
globalce-157	235	64	maude	maude	PROPN
globalce-157	235	65	database	database	PROPN
globalce-157	235	66	j	j	PROPN
globalce-157	235	67	global	global	ADJ
globalce-157	235	68	clinical	clinical	ADJ
globalce-157	235	69	engineering	engineering	PROPN
globalce-157	235	70	vol.6	vol.6	PROPN
globalce-157	235	71	issue	issue	NOUN
globalce-157	235	72	1	1	NUM
globalce-157	235	73	:	:	SYM
globalce-157	235	74	2023	2023	NUM
globalce-157	235	75	16	16	NUM
globalce-157	235	76	description	description	NOUN
globalce-157	235	77	.	.	PUNCT
globalce-157	236	1	however	however	ADV
globalce-157	236	2	,	,	PUNCT
globalce-157	236	3	the	the	DET
globalce-157	236	4	data	datum	NOUN
globalce-157	236	5	contained	contain	VERB
globalce-157	236	6	in	in	ADP
globalce-157	236	7	these	these	DET
globalce-157	236	8	files	file	NOUN
globalce-157	236	9	are	be	AUX
globalce-157	236	10	interchanged	interchange	VERB
globalce-157	236	11	.	.	PUNCT
globalce-157	237	1	additionally	additionally	ADV
globalce-157	237	2	,	,	PUNCT
globalce-157	237	3	“	"	PUNCT
globalce-157	237	4	mdrfoi	mdrfoi	VERB
globalce-157	237	5	”	"	PUNCT
globalce-157	237	6	file	file	NOUN
globalce-157	237	7	’s	’s	PART
globalce-157	237	8	description	description	NOUN
globalce-157	237	9	was	be	AUX
globalce-157	237	10	not	not	PART
globalce-157	237	11	updated	update	VERB
globalce-157	237	12	for	for	ADP
globalce-157	237	13	the	the	DET
globalce-157	237	14	current	current	ADJ
globalce-157	237	15	year	year	NOUN
globalce-157	237	16	,	,	PUNCT
globalce-157	237	17	at	at	ADP
globalce-157	237	18	the	the	DET
globalce-157	237	19	time	time	NOUN
globalce-157	237	20	of	of	ADP
globalce-157	237	21	this	this	DET
globalce-157	237	22	work	work	NOUN
globalce-157	237	23	.	.	PUNCT
globalce-157	238	1	though	though	SCONJ
globalce-157	238	2	it	it	PRON
globalce-157	238	3	contained	contain	VERB
globalce-157	238	4	data	datum	NOUN
globalce-157	238	5	from	from	ADP
globalce-157	238	6	2023	2023	NUM
globalce-157	238	7	,	,	PUNCT
globalce-157	238	8	it	it	PRON
globalce-157	238	9	read	read	VERB
globalce-157	238	10	“	"	PUNCT
globalce-157	238	11	maude	maude	NOUN
globalce-157	238	12	base	base	NOUN
globalce-157	238	13	records	record	NOUN
globalce-157	238	14	received	receive	VERB
globalce-157	238	15	for	for	ADP
globalce-157	238	16	2022	2022	NUM
globalce-157	238	17	”	"	PUNCT
globalce-157	238	18	.	.	PUNCT
globalce-157	239	1	the	the	DET
globalce-157	239	2	mdrfoithruxxxx	mdrfoithruxxxx	NOUN
globalce-157	239	3	file	file	NOUN
globalce-157	239	4	also	also	ADV
globalce-157	239	5	contains	contain	VERB
globalce-157	239	6	a	a	DET
globalce-157	239	7	vast	vast	ADJ
globalce-157	239	8	amount	amount	NOUN
globalce-157	239	9	of	of	ADP
globalce-157	239	10	information	information	NOUN
globalce-157	239	11	of	of	ADP
globalce-157	239	12	5	5	NUM
globalce-157	239	13	gb	gb	NOUN
globalce-157	239	14	,	,	PUNCT
globalce-157	239	15	making	make	VERB
globalce-157	239	16	it	it	PRON
globalce-157	239	17	difficult	difficult	ADJ
globalce-157	239	18	for	for	SCONJ
globalce-157	239	19	casual	casual	ADJ
globalce-157	239	20	users	user	NOUN
globalce-157	239	21	to	to	PART
globalce-157	239	22	access	access	VERB
globalce-157	239	23	it	it	PRON
globalce-157	239	24	.	.	PUNCT
globalce-157	240	1	splitting	split	VERB
globalce-157	240	2	it	it	PRON
globalce-157	240	3	as	as	SCONJ
globalce-157	240	4	is	be	AUX
globalce-157	240	5	the	the	DET
globalce-157	240	6	case	case	NOUN
globalce-157	240	7	with	with	SCONJ
globalce-157	240	8	device	device	NOUN
globalce-157	240	9	files	file	NOUN
globalce-157	240	10	would	would	AUX
globalce-157	240	11	facilitate	facilitate	VERB
globalce-157	240	12	further	further	ADJ
globalce-157	240	13	database	database	NOUN
globalce-157	240	14	usage	usage	NOUN
globalce-157	240	15	.	.	PUNCT
globalce-157	241	1	other	other	ADJ
globalce-157	241	2	shortcomings	shortcoming	NOUN
globalce-157	241	3	of	of	ADP
globalce-157	241	4	maude	maude	PROPN
globalce-157	241	5	derive	derive	PROPN
globalce-157	241	6	from	from	ADP
globalce-157	241	7	adverse	adverse	ADJ
globalce-157	241	8	event	event	NOUN
globalce-157	241	9	reporting	report	VERB
globalce-157	241	10	system	system	NOUN
globalce-157	241	11	issues	issue	NOUN
globalce-157	241	12	.	.	PUNCT
globalce-157	242	1	a	a	DET
globalce-157	242	2	common	common	ADJ
globalce-157	242	3	problem	problem	NOUN
globalce-157	242	4	for	for	ADP
globalce-157	242	5	all	all	DET
globalce-157	242	6	vigilance	vigilance	NOUN
globalce-157	242	7	systems	system	NOUN
globalce-157	242	8	worldwide	worldwide	ADV
globalce-157	242	9	is	be	AUX
globalce-157	242	10	underreporting	underreporte	VERB
globalce-157	242	11	adverse	adverse	ADJ
globalce-157	242	12	events	event	NOUN
globalce-157	242	13	.	.	PUNCT
globalce-157	243	1	though	though	SCONJ
globalce-157	243	2	events	event	NOUN
globalce-157	243	3	seem	seem	VERB
globalce-157	243	4	to	to	PART
globalce-157	243	5	be	be	AUX
globalce-157	243	6	reported	report	VERB
globalce-157	243	7	more	more	ADV
globalce-157	243	8	frequently	frequently	ADV
globalce-157	243	9	during	during	ADP
globalce-157	243	10	the	the	DET
globalce-157	243	11	last	last	ADJ
globalce-157	243	12	years	year	NOUN
globalce-157	243	13	,	,	PUNCT
globalce-157	243	14	it	it	PRON
globalce-157	243	15	is	be	AUX
globalce-157	243	16	still	still	ADV
globalce-157	243	17	plausible	plausible	ADJ
globalce-157	243	18	that	that	SCONJ
globalce-157	243	19	more	more	ADV
globalce-157	243	20	adverse	adverse	ADJ
globalce-157	243	21	events	event	NOUN
globalce-157	243	22	occur	occur	VERB
globalce-157	243	23	than	than	ADP
globalce-157	243	24	those	those	PRON
globalce-157	243	25	finally	finally	ADV
globalce-157	243	26	reported	report	VERB
globalce-157	243	27	to	to	ADP
globalce-157	243	28	the	the	DET
globalce-157	243	29	fda	fda	PROPN
globalce-157	243	30	.	.	PUNCT
globalce-157	244	1	the	the	DET
globalce-157	244	2	rate	rate	NOUN
globalce-157	244	3	of	of	ADP
globalce-157	244	4	medical	medical	ADJ
globalce-157	244	5	device	device	NOUN
globalce-157	244	6	adverse	adverse	ADJ
globalce-157	244	7	events	event	NOUN
globalce-157	244	8	underreporting	underreporte	VERB
globalce-157	244	9	is	be	AUX
globalce-157	244	10	difficult	difficult	ADJ
globalce-157	244	11	to	to	PART
globalce-157	244	12	determine	determine	VERB
globalce-157	244	13	,	,	PUNCT
globalce-157	244	14	as	as	SCONJ
globalce-157	244	15	the	the	DET
globalce-157	244	16	number	number	NOUN
globalce-157	244	17	of	of	ADP
globalce-157	244	18	incidents	incident	NOUN
globalce-157	244	19	is	be	AUX
globalce-157	244	20	unknown	unknown	ADJ
globalce-157	244	21	accurately	accurately	ADV
globalce-157	244	22	.	.	PUNCT
globalce-157	245	1	non	non	ADJ
globalce-157	245	2	-	-	ADJ
globalce-157	245	3	reporting	reporting	NOUN
globalce-157	245	4	can	can	AUX
globalce-157	245	5	be	be	AUX
globalce-157	245	6	attributed	attribute	VERB
globalce-157	245	7	to	to	ADP
globalce-157	245	8	many	many	ADJ
globalce-157	245	9	factors	factor	NOUN
globalce-157	245	10	,	,	PUNCT
globalce-157	245	11	such	such	ADJ
globalce-157	245	12	as	as	ADP
globalce-157	245	13	fear	fear	NOUN
globalce-157	245	14	of	of	ADP
globalce-157	245	15	blame	blame	NOUN
globalce-157	245	16	,	,	PUNCT
globalce-157	245	17	lack	lack	NOUN
globalce-157	245	18	of	of	ADP
globalce-157	245	19	time	time	NOUN
globalce-157	245	20	,	,	PUNCT
globalce-157	245	21	complexity	complexity	NOUN
globalce-157	245	22	of	of	ADP
globalce-157	245	23	the	the	DET
globalce-157	245	24	reporting	reporting	NOUN
globalce-157	245	25	system	system	NOUN
globalce-157	245	26	,	,	PUNCT
globalce-157	245	27	or	or	CCONJ
globalce-157	245	28	even	even	ADV
globalce-157	245	29	perceived	perceive	VERB
globalce-157	245	30	ineffectiveness	ineffectiveness	NOUN
globalce-157	245	31	.	.	PUNCT
globalce-157	246	1	adding	add	VERB
globalce-157	246	2	to	to	ADP
globalce-157	246	3	this	this	PRON
globalce-157	246	4	,	,	PUNCT
globalce-157	246	5	in	in	ADP
globalce-157	246	6	cases	case	NOUN
globalce-157	246	7	of	of	ADP
globalce-157	246	8	human	human	ADJ
globalce-157	246	9	error	error	NOUN
globalce-157	246	10	,	,	PUNCT
globalce-157	246	11	underreporting	underreporte	VERB
globalce-157	246	12	is	be	AUX
globalce-157	246	13	expected	expect	VERB
globalce-157	246	14	to	to	PART
globalce-157	246	15	be	be	AUX
globalce-157	246	16	even	even	ADV
globalce-157	246	17	more	more	ADV
globalce-157	246	18	prevalent.24,25	prevalent.24,25	ADJ
globalce-157	246	19	other	other	ADJ
globalce-157	246	20	issues	issue	NOUN
globalce-157	246	21	may	may	AUX
globalce-157	246	22	be	be	AUX
globalce-157	246	23	the	the	DET
globalce-157	246	24	symptoms	symptom	NOUN
globalce-157	246	25	of	of	ADP
globalce-157	246	26	underutilizing	underutilize	VERB
globalce-157	246	27	the	the	DET
globalce-157	246	28	mdr	mdr	PROPN
globalce-157	246	29	system	system	NOUN
globalce-157	246	30	’s	’s	PART
globalce-157	246	31	potential	potential	NOUN
globalce-157	246	32	.	.	PUNCT
globalce-157	247	1	for	for	ADP
globalce-157	247	2	example	example	NOUN
globalce-157	247	3	,	,	PUNCT
globalce-157	247	4	although	although	SCONJ
globalce-157	247	5	more	more	ADJ
globalce-157	247	6	than	than	ADP
globalce-157	247	7	one	one	NUM
globalce-157	247	8	remedial	remedial	ADJ
globalce-157	247	9	action	action	NOUN
globalce-157	247	10	code	code	NOUN
globalce-157	247	11	can	can	AUX
globalce-157	247	12	be	be	AUX
globalce-157	247	13	assigned	assign	VERB
globalce-157	247	14	to	to	ADP
globalce-157	247	15	an	an	DET
globalce-157	247	16	adverse	adverse	ADJ
globalce-157	247	17	event	event	NOUN
globalce-157	247	18	,	,	PUNCT
globalce-157	247	19	in	in	ADP
globalce-157	247	20	practice	practice	NOUN
globalce-157	247	21	reports	report	NOUN
globalce-157	247	22	in	in	ADP
globalce-157	247	23	maude	maude	NOUN
globalce-157	247	24	,	,	PUNCT
globalce-157	247	25	use	use	VERB
globalce-157	247	26	a	a	DET
globalce-157	247	27	single	single	ADJ
globalce-157	247	28	code	code	NOUN
globalce-157	247	29	.	.	PUNCT
globalce-157	248	1	as	as	ADP
globalce-157	248	2	a	a	DET
globalce-157	248	3	result	result	NOUN
globalce-157	248	4	,	,	PUNCT
globalce-157	248	5	when	when	SCONJ
globalce-157	248	6	an	an	DET
globalce-157	248	7	event	event	NOUN
globalce-157	248	8	is	be	AUX
globalce-157	248	9	marked	mark	VERB
globalce-157	248	10	with	with	ADP
globalce-157	248	11	a	a	DET
globalce-157	248	12	corrective	corrective	ADJ
globalce-157	248	13	action	action	NOUN
globalce-157	248	14	(	(	PUNCT
globalce-157	248	15	i.e.	i.e.	X
globalce-157	248	16	replacement	replacement	NOUN
globalce-157	248	17	of	of	ADP
globalce-157	248	18	the	the	DET
globalce-157	248	19	device	device	NOUN
globalce-157	248	20	)	)	PUNCT
globalce-157	248	21	,	,	PUNCT
globalce-157	248	22	the	the	DET
globalce-157	248	23	recall	recall	PROPN
globalce-157	248	24	code	code	NOUN
globalce-157	248	25	is	be	AUX
globalce-157	248	26	omitted	omit	VERB
globalce-157	248	27	and	and	CCONJ
globalce-157	248	28	vice	vice	ADV
globalce-157	248	29	versa	versa	ADV
globalce-157	248	30	.	.	PUNCT
globalce-157	249	1	therefore	therefore	ADV
globalce-157	249	2	,	,	PUNCT
globalce-157	249	3	it	it	PRON
globalce-157	249	4	becomes	become	VERB
globalce-157	249	5	unclear	unclear	ADJ
globalce-157	249	6	whether	whether	SCONJ
globalce-157	249	7	the	the	DET
globalce-157	249	8	corrective	corrective	ADJ
globalce-157	249	9	action	action	NOUN
globalce-157	249	10	was	be	AUX
globalce-157	249	11	part	part	NOUN
globalce-157	249	12	of	of	ADP
globalce-157	249	13	a	a	DET
globalce-157	249	14	recall	recall	NOUN
globalce-157	249	15	,	,	PUNCT
globalce-157	249	16	or	or	CCONJ
globalce-157	249	17	a	a	DET
globalce-157	249	18	voluntary	voluntary	ADJ
globalce-157	249	19	preventive	preventive	ADJ
globalce-157	249	20	manufacturer	manufacturer	NOUN
globalce-157	249	21	action	action	NOUN
globalce-157	249	22	.	.	PUNCT
globalce-157	250	1	finally	finally	ADV
globalce-157	250	2	,	,	PUNCT
globalce-157	250	3	it	it	PRON
globalce-157	250	4	is	be	AUX
globalce-157	250	5	important	important	ADJ
globalce-157	250	6	to	to	PART
globalce-157	250	7	note	note	VERB
globalce-157	250	8	that	that	SCONJ
globalce-157	250	9	an	an	DET
globalce-157	250	10	increase	increase	NOUN
globalce-157	250	11	in	in	ADP
globalce-157	250	12	adverse	adverse	ADJ
globalce-157	250	13	event	event	NOUN
globalce-157	250	14	reports	report	NOUN
globalce-157	250	15	does	do	AUX
globalce-157	250	16	not	not	PART
globalce-157	250	17	necessarily	necessarily	ADV
globalce-157	250	18	mean	mean	VERB
globalce-157	250	19	that	that	SCONJ
globalce-157	250	20	the	the	DET
globalce-157	250	21	number	number	NOUN
globalce-157	250	22	of	of	ADP
globalce-157	250	23	adverse	adverse	ADJ
globalce-157	250	24	events	event	NOUN
globalce-157	250	25	has	have	AUX
globalce-157	250	26	increased	increase	VERB
globalce-157	250	27	,	,	PUNCT
globalce-157	250	28	but	but	CCONJ
globalce-157	250	29	rather	rather	ADV
globalce-157	250	30	that	that	SCONJ
globalce-157	250	31	reporting	reporting	NOUN
globalce-157	250	32	systems	system	NOUN
globalce-157	250	33	have	have	AUX
globalce-157	250	34	become	become	VERB
globalce-157	250	35	more	more	ADV
globalce-157	250	36	effective	effective	ADJ
globalce-157	250	37	in	in	ADP
globalce-157	250	38	capturing	capture	VERB
globalce-157	250	39	and	and	CCONJ
globalce-157	250	40	documenting	document	VERB
globalce-157	250	41	these	these	DET
globalce-157	250	42	events	event	NOUN
globalce-157	250	43	.	.	PUNCT
globalce-157	251	1	conclusions	conclusion	NOUN
globalce-157	251	2	it	it	PRON
globalce-157	251	3	is	be	AUX
globalce-157	251	4	obvious	obvious	ADJ
globalce-157	251	5	that	that	SCONJ
globalce-157	251	6	the	the	DET
globalce-157	251	7	fda	fda	PROPN
globalce-157	251	8	encourages	encourage	VERB
globalce-157	251	9	reporting	report	VERB
globalce-157	251	10	adverse	adverse	ADJ
globalce-157	251	11	events	event	NOUN
globalce-157	251	12	and	and	CCONJ
globalce-157	251	13	maude	maude	NOUN
globalce-157	251	14	plays	play	VERB
globalce-157	251	15	an	an	DET
globalce-157	251	16	essential	essential	ADJ
globalce-157	251	17	role	role	NOUN
globalce-157	251	18	in	in	ADP
globalce-157	251	19	identifying	identify	VERB
globalce-157	251	20	potential	potential	ADJ
globalce-157	251	21	safety	safety	NOUN
globalce-157	251	22	issues	issue	NOUN
globalce-157	251	23	and	and	CCONJ
globalce-157	251	24	facilitating	facilitate	VERB
globalce-157	251	25	corrective	corrective	ADJ
globalce-157	251	26	actions	action	NOUN
globalce-157	251	27	that	that	PRON
globalce-157	251	28	protect	protect	VERB
globalce-157	251	29	public	public	ADJ
globalce-157	251	30	health	health	NOUN
globalce-157	251	31	.	.	PUNCT
globalce-157	252	1	it	it	PRON
globalce-157	252	2	also	also	ADV
globalce-157	252	3	provides	provide	VERB
globalce-157	252	4	an	an	DET
globalce-157	252	5	essential	essential	ADJ
globalce-157	252	6	source	source	NOUN
globalce-157	252	7	of	of	ADP
globalce-157	252	8	data	datum	NOUN
globalce-157	252	9	for	for	ADP
globalce-157	252	10	review	review	NOUN
globalce-157	252	11	studies	study	NOUN
globalce-157	252	12	in	in	ADP
globalce-157	252	13	this	this	DET
globalce-157	252	14	area	area	NOUN
globalce-157	252	15	,	,	PUNCT
globalce-157	252	16	as	as	SCONJ
globalce-157	252	17	demonstrated	demonstrate	VERB
globalce-157	252	18	by	by	ADP
globalce-157	252	19	the	the	DET
globalce-157	252	20	increasing	increase	VERB
globalce-157	252	21	number	number	NOUN
globalce-157	252	22	of	of	ADP
globalce-157	252	23	related	related	ADJ
globalce-157	252	24	publications	publication	NOUN
globalce-157	252	25	mentioned	mention	VERB
globalce-157	252	26	in	in	ADP
globalce-157	252	27	the	the	DET
globalce-157	252	28	introduction	introduction	NOUN
globalce-157	252	29	.	.	PUNCT
globalce-157	253	1	in	in	ADP
globalce-157	253	2	europe	europe	PROPN
globalce-157	253	3	,	,	PUNCT
globalce-157	253	4	despite	despite	SCONJ
globalce-157	253	5	the	the	DET
globalce-157	253	6	explicit	explicit	ADJ
globalce-157	253	7	reference	reference	NOUN
globalce-157	253	8	in	in	ADP
globalce-157	253	9	the	the	DET
globalce-157	253	10	md	md	PROPN
globalce-157	253	11	regulations	regulation	NOUN
globalce-157	253	12	on	on	ADP
globalce-157	253	13	the	the	DET
globalce-157	253	14	availability	availability	NOUN
globalce-157	253	15	of	of	ADP
globalce-157	253	16	the	the	DET
globalce-157	253	17	vigilance	vigilance	NOUN
globalce-157	253	18	data	datum	NOUN
globalce-157	253	19	in	in	ADP
globalce-157	253	20	the	the	DET
globalce-157	253	21	eudamed	eudame	VERB
globalce-157	253	22	,	,	PUNCT
globalce-157	253	23	this	this	DET
globalce-157	253	24	part	part	NOUN
globalce-157	253	25	of	of	ADP
globalce-157	253	26	the	the	DET
globalce-157	253	27	database	database	NOUN
globalce-157	253	28	is	be	AUX
globalce-157	253	29	still	still	ADV
globalce-157	253	30	not	not	PART
globalce-157	253	31	accessible	accessible	ADJ
globalce-157	253	32	.	.	PUNCT
globalce-157	254	1	this	this	DET
globalce-157	254	2	fact	fact	NOUN
globalce-157	254	3	restricts	restrict	VERB
globalce-157	254	4	the	the	DET
globalce-157	254	5	utilization	utilization	NOUN
globalce-157	254	6	of	of	ADP
globalce-157	254	7	this	this	DET
globalce-157	254	8	critical	critical	ADJ
globalce-157	254	9	data	datum	NOUN
globalce-157	254	10	for	for	ADP
globalce-157	254	11	advancing	advance	VERB
globalce-157	254	12	safety	safety	NOUN
globalce-157	254	13	in	in	ADP
globalce-157	254	14	medical	medical	ADJ
globalce-157	254	15	technology	technology	NOUN
globalce-157	254	16	in	in	ADP
globalce-157	254	17	europe	europe	PROPN
globalce-157	254	18	and	and	CCONJ
globalce-157	254	19	worldwide	worldwide	ADV
globalce-157	254	20	.	.	PUNCT
globalce-157	255	1	in	in	ADP
globalce-157	255	2	conclusion	conclusion	NOUN
globalce-157	255	3	,	,	PUNCT
globalce-157	255	4	using	use	VERB
globalce-157	255	5	an	an	DET
globalce-157	255	6	adverse	adverse	ADJ
globalce-157	255	7	event	event	NOUN
globalce-157	255	8	reporting	report	VERB
globalce-157	255	9	system	system	NOUN
globalce-157	255	10	efficiently	efficiently	ADV
globalce-157	255	11	facilitates	facilitate	VERB
globalce-157	255	12	communication	communication	NOUN
globalce-157	255	13	between	between	ADP
globalce-157	255	14	regulatory	regulatory	ADJ
globalce-157	255	15	agencies	agency	NOUN
globalce-157	255	16	and	and	CCONJ
globalce-157	255	17	healthcare	healthcare	NOUN
globalce-157	255	18	providers	provider	NOUN
globalce-157	255	19	and	and	CCONJ
globalce-157	255	20	promotes	promote	VERB
globalce-157	255	21	transparency	transparency	NOUN
globalce-157	255	22	and	and	CCONJ
globalce-157	255	23	accountability	accountability	NOUN
globalce-157	255	24	in	in	ADP
globalce-157	255	25	the	the	DET
globalce-157	255	26	healthcare	healthcare	NOUN
globalce-157	255	27	industry	industry	NOUN
globalce-157	255	28	.	.	PUNCT
globalce-157	256	1	ensuring	ensure	VERB
globalce-157	256	2	that	that	SCONJ
globalce-157	256	3	mds	mds	PROPN
globalce-157	256	4	are	be	AUX
globalce-157	256	5	safe	safe	ADJ
globalce-157	256	6	and	and	CCONJ
globalce-157	256	7	effective	effective	ADJ
globalce-157	256	8	will	will	AUX
globalce-157	256	9	improve	improve	VERB
globalce-157	256	10	patient	patient	ADJ
globalce-157	256	11	outcomes	outcome	NOUN
globalce-157	256	12	,	,	PUNCT
globalce-157	256	13	with	with	ADP
globalce-157	256	14	clear	clear	ADJ
globalce-157	256	15	benefits	benefit	NOUN
globalce-157	256	16	for	for	ADP
globalce-157	256	17	the	the	DET
globalce-157	256	18	healthcare	healthcare	NOUN
globalce-157	256	19	sector	sector	NOUN
globalce-157	256	20	that	that	PRON
globalce-157	256	21	remains	remain	VERB
globalce-157	256	22	a	a	DET
globalce-157	256	23	cornerstone	cornerstone	NOUN
globalce-157	256	24	of	of	ADP
globalce-157	256	25	our	our	PRON
globalce-157	256	26	society	society	NOUN
globalce-157	256	27	.	.	PUNCT
globalce-157	257	1	references	reference	NOUN
globalce-157	257	2	1	1	NUM
globalce-157	257	3	.	.	PUNCT
globalce-157	258	1	wiig	wiig	PROPN
globalce-157	258	2	s	s	PROPN
globalce-157	258	3	,	,	PUNCT
globalce-157	258	4	aase	aase	PROPN
globalce-157	258	5	k	k	PROPN
globalce-157	258	6	,	,	PUNCT
globalce-157	258	7	bourrier	bourri	ADJ
globalce-157	258	8	m	m	PROPN
globalce-157	258	9	,	,	PUNCT
globalce-157	258	10	roise	roise	VERB
globalce-157	258	11	o.transparency	o.transparency	NOUN
globalce-157	258	12	in	in	ADP
globalce-157	258	13	health	health	NOUN
globalce-157	258	14	care	care	NOUN
globalce-157	258	15	:	:	PUNCT
globalce-157	258	16	disclosing	disclose	VERB
globalce-157	258	17	adverse	adverse	ADJ
globalce-157	258	18	events	event	NOUN
globalce-157	258	19	to	to	ADP
globalce-157	258	20	the	the	DET
globalce-157	258	21	public	public	NOUN
globalce-157	258	22	|	|	ADV
globalce-157	258	23	springerlink	springerlink	VERB
globalce-157	259	1	[	[	X
globalce-157	259	2	internet	internet	NOUN
globalce-157	259	3	]	]	PUNCT
globalce-157	259	4	.	.	PUNCT
globalce-157	260	1	[	[	X
globalce-157	260	2	cited	cite	VERB
globalce-157	260	3	2023	2023	NUM
globalce-157	260	4	may	may	AUX
globalce-157	260	5	5	5	NUM
globalce-157	260	6	]	]	PUNCT
globalce-157	260	7	.	.	PUNCT
globalce-157	261	1	available	available	ADJ
globalce-157	261	2	from	from	ADP
globalce-157	261	3	:	:	PUNCT
globalce-157	261	4	https://link.springer.com/	https://link.springer.com/	PROPN
globalce-157	261	5	chapter/10.1007/978	chapter/10.1007/978	PROPN
globalce-157	261	6	-	-	SYM
globalce-157	261	7	3	3	NUM
globalce-157	261	8	-	-	NUM
globalce-157	261	9	319	319	NUM
globalce-157	261	10	-	-	PUNCT
globalce-157	261	11	74098	74098	NUM
globalce-157	261	12	-	-	PUNCT
globalce-157	261	13	0_8	0_8	NUM
globalce-157	261	14	2	2	NUM
globalce-157	261	15	.	.	PUNCT
globalce-157	262	1	fda	fda	PROPN
globalce-157	262	2	.	.	PUNCT
globalce-157	263	1	about	about	ADP
globalce-157	263	2	manufacturer	manufacturer	NOUN
globalce-157	263	3	and	and	CCONJ
globalce-157	263	4	user	user	NOUN
globalce-157	263	5	facility	facility	NOUN
globalce-157	263	6	device	device	NOUN
globalce-157	263	7	experience	experience	NOUN
globalce-157	263	8	(	(	PUNCT
globalce-157	263	9	maude	maude	NOUN
globalce-157	263	10	)	)	PUNCT
globalce-157	264	1	[	[	X
globalce-157	264	2	internet	internet	NOUN
globalce-157	264	3	]	]	PUNCT
globalce-157	264	4	.	.	PUNCT
globalce-157	265	1	fda	fda	PROPN
globalce-157	265	2	;	;	PUNCT
globalce-157	265	3	2023	2023	NUM
globalce-157	266	1	[	[	X
globalce-157	266	2	cited	cite	VERB
globalce-157	266	3	2023	2023	NUM
globalce-157	266	4	apr	apr	NOUN
globalce-157	266	5	11	11	NUM
globalce-157	266	6	]	]	PUNCT
globalce-157	266	7	.	.	PUNCT
globalce-157	267	1	available	available	ADJ
globalce-157	267	2	from	from	ADP
globalce-157	267	3	:	:	PUNCT
globalce-157	267	4	https://www.fda.gov/	https://www.fda.gov/	PROPN
globalce-157	267	5	medical	medical	ADJ
globalce-157	267	6	-	-	PUNCT
globalce-157	267	7	devices	device	NOUN
globalce-157	267	8	/	/	SYM
globalce-157	267	9	mandatory	mandatory	ADJ
globalce-157	267	10	-	-	PUNCT
globalce-157	267	11	reporting	reporting	NOUN
globalce-157	267	12	-	-	PUNCT
globalce-157	267	13	requirementsmanufacturers	requirementsmanufacturer	NOUN
globalce-157	267	14	-	-	PUNCT
globalce-157	267	15	importers	importer	NOUN
globalce-157	267	16	-	-	PUNCT
globalce-157	267	17	and	and	CCONJ
globalce-157	267	18	-	-	PUNCT
globalce-157	267	19	device	device	NOUN
globalce-157	267	20	-	-	PUNCT
globalce-157	267	21	user	user	NOUN
globalce-157	267	22	-	-	PUNCT
globalce-157	267	23	facilities/	facilities/	NOUN
globalce-157	267	24	about	about	ADP
globalce-157	267	25	-	-	PUNCT
globalce-157	267	26	manufacturer	manufacturer	NOUN
globalce-157	267	27	-	-	PUNCT
globalce-157	267	28	and	and	CCONJ
globalce-157	267	29	-	-	PUNCT
globalce-157	267	30	user	user	NOUN
globalce-157	267	31	-	-	PUNCT
globalce-157	267	32	facility	facility	NOUN
globalce-157	267	33	-	-	PUNCT
globalce-157	267	34	device	device	NOUN
globalce-157	267	35	-	-	PUNCT
globalce-157	267	36	experience	experience	NOUN
globalce-157	267	37	-	-	PUNCT
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globalce-157	267	39	3	3	PROPN
globalce-157	267	40	.	.	PUNCT
globalce-157	267	41	fda	fda	PROPN
globalce-157	267	42	.	.	PROPN
globalce-157	268	1	2023	2023	NUM
globalce-157	268	2	medical	medical	ADJ
globalce-157	268	3	device	device	NOUN
globalce-157	268	4	reporting	reporting	NOUN
globalce-157	268	5	(	(	PUNCT
globalce-157	268	6	mdr	mdr	NOUN
globalce-157	268	7	):	):	PUNCT
globalce-157	268	8	how	how	SCONJ
globalce-157	268	9	to	to	PART
globalce-157	268	10	report	report	VERB
globalce-157	268	11	medical	medical	ADJ
globalce-157	268	12	device	device	NOUN
globalce-157	268	13	problems	problem	NOUN
globalce-157	268	14	.	.	PUNCT
globalce-157	269	1	[	[	X
globalce-157	269	2	cited	cite	VERB
globalce-157	269	3	2023	2023	NUM
globalce-157	269	4	apr	apr	NOUN
globalce-157	269	5	11	11	NUM
globalce-157	269	6	]	]	PUNCT
globalce-157	269	7	.	.	PUNCT
globalce-157	270	1	available	available	ADJ
globalce-157	270	2	from	from	ADP
globalce-157	270	3	:	:	PUNCT
globalce-157	270	4	https://www.fda.gov/medical-devices/	https://www.fda.gov/medical-devices/	PROPN
globalce-157	270	5	medical	medical	ADJ
globalce-157	270	6	-	-	PUNCT
globalce-157	270	7	device	device	NOUN
globalce-157	270	8	-	-	PUNCT
globalce-157	270	9	safety	safety	NOUN
globalce-157	270	10	/	/	SYM
globalce-157	270	11	medical	medical	ADJ
globalce-157	270	12	-	-	PUNCT
globalce-157	270	13	device	device	NOUN
globalce-157	270	14	-	-	PUNCT
globalce-157	270	15	reporting	reporting	NOUN
globalce-157	270	16	-	-	PUNCT
globalce-157	270	17	mdrhow	mdrhow	NOUN
globalce-157	270	18	-	-	PUNCT
globalce-157	270	19	report	report	NOUN
globalce-157	270	20	-	-	PUNCT
globalce-157	270	21	medical	medical	ADJ
globalce-157	270	22	-	-	PUNCT
globalce-157	270	23	device	device	NOUN
globalce-157	270	24	-	-	PUNCT
globalce-157	270	25	problems	problem	NOUN
globalce-157	270	26	4	4	NUM
globalce-157	270	27	.	.	PUNCT
globalce-157	270	28	eudamed	eudame	VERB
globalce-157	270	29	database	database	NOUN
globalce-157	270	30	eudamed	eudame	VERB
globalce-157	270	31	[	[	PUNCT
globalce-157	270	32	internet	internet	NOUN
globalce-157	270	33	]	]	PUNCT
globalce-157	270	34	.	.	PUNCT
globalce-157	271	1	[	[	X
globalce-157	271	2	cited	cite	VERB
globalce-157	271	3	2023	2023	NUM
globalce-157	271	4	apr	apr	NOUN
globalce-157	271	5	11	11	NUM
globalce-157	271	6	]	]	PUNCT
globalce-157	271	7	.	.	PUNCT
globalce-157	272	1	available	available	ADJ
globalce-157	272	2	from	from	ADP
globalce-157	272	3	:	:	PUNCT
globalce-157	272	4	https://ec.europa.eu/	https://ec.europa.eu/	VERB
globalce-157	272	5	tools	tool	NOUN
globalce-157	272	6	/	/	SYM
globalce-157	272	7	eudamed/#/screen	eudamed/#/screen	NOUN
globalce-157	272	8	/	/	SYM
globalce-157	272	9	home	home	NOUN
globalce-157	272	10	5	5	NUM
globalce-157	272	11	.	.	PUNCT
globalce-157	273	1	government	government	NOUN
globalce-157	273	2	of	of	ADP
globalce-157	273	3	australia	australia	PROPN
globalce-157	273	4	department	department	PROPN
globalce-157	273	5	of	of	ADP
globalce-157	273	6	health	health	PROPN
globalce-157	273	7	and	and	CCONJ
globalce-157	273	8	aged	aged	ADJ
globalce-157	273	9	care	care	NOUN
globalce-157	273	10	.	.	PUNCT
globalce-157	274	1	therapeutic	therapeutic	ADJ
globalce-157	274	2	goods	good	NOUN
globalce-157	274	3	administration	administration	NOUN
globalce-157	274	4	(	(	PUNCT
globalce-157	274	5	tga	tga	PROPN
globalce-157	274	6	)	)	PUNCT
globalce-157	274	7	.	.	PUNCT
globalce-157	275	1	safety	safety	NOUN
globalce-157	275	2	monitoring	monitoring	NOUN
globalce-157	275	3	:	:	PUNCT
globalce-157	275	4	medical	medical	ADJ
globalce-157	275	5	devices	device	NOUN
globalce-157	276	1	[	[	X
globalce-157	276	2	internet	internet	NOUN
globalce-157	276	3	]	]	X
globalce-157	276	4	.	.	PUNCT
globalce-157	277	1	2022	2022	NUM
globalce-157	278	1	[	[	X
globalce-157	278	2	cited	cite	VERB
globalce-157	278	3	2023	2023	NUM
globalce-157	278	4	apr	apr	NOUN
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globalce-157	278	7	.	.	PUNCT
globalce-157	279	1	available	available	ADJ
globalce-157	279	2	from	from	ADP
globalce-157	279	3	:	:	PUNCT
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globalce-157	279	5	.	.	PUNCT
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globalce-157	279	7	/	/	SYM
globalce-157	279	8	safety	safety	NOUN
globalce-157	279	9	/	/	SYM
globalce-157	279	10	safety	safety	NOUN
globalce-157	279	11	/	/	SYM
globalce-157	279	12	safety	safety	NOUN
globalce-157	279	13	-	-	PUNCT
globalce-157	279	14	monitoring	monitoring	NOUN
globalce-157	279	15	-	-	PUNCT
globalce-157	279	16	medical	medical	ADJ
globalce-157	279	17	-	-	PUNCT
globalce-157	279	18	devices	device	NOUN
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globalce-157	279	20	https://link.springer.com/chapter/10.1007/978-3-319-74098-0_8	https://link.springer.com/chapter/10.1007/978-3-319-74098-0_8	PROPN
globalce-157	279	21	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
globalce-157	279	22	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
globalce-157	279	23	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
globalce-157	279	24	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude	NOUN
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globalce-157	279	27	https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems	https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problem	NOUN
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globalce-157	279	29	https://ec.europa.eu/tools/eudamed/#/screen/home	https://ec.europa.eu/tools/eudamed/#/screen/home	NOUN
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globalce-157	279	31	https://www.tga.gov.au/safety/safety/safety-monitoring-medical-devices	https://www.tga.gov.au/safety/safety/safety-monitoring-medical-devices	AUX
globalce-157	279	32	17	17	NUM
globalce-157	279	33	j	j	PROPN
globalce-157	279	34	global	global	ADJ
globalce-157	279	35	clinical	clinical	ADJ
globalce-157	279	36	engineering	engineering	PROPN
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globalce-157	279	39	1	1	NUM
globalce-157	279	40	:	:	SYM
globalce-157	279	41	2023	2023	NUM
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globalce-157	279	49	adverse	adverse	ADJ
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globalce-157	279	52	in	in	ADP
globalce-157	279	53	fda	fda	PROPN
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globalce-157	279	55	maude	maude	PROPN
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globalce-157	279	58	.	.	PUNCT
globalce-157	280	1	government	government	NOUN
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globalce-157	280	3	canada	canada	PROPN
globalce-157	280	4	health	health	PROPN
globalce-157	280	5	canada	canada	PROPN
globalce-157	280	6	.	.	PUNCT
globalce-157	281	1	find	find	VERB
globalce-157	281	2	recalls	recall	NOUN
globalce-157	281	3	,	,	PUNCT
globalce-157	281	4	advisories	advisory	NOUN
globalce-157	281	5	and	and	CCONJ
globalce-157	281	6	safety	safety	NOUN
globalce-157	281	7	alerts	alert	NOUN
globalce-157	281	8	–	–	PUNCT
globalce-157	281	9	canada.ca	canada.ca	NOUN
globalce-157	282	1	[	[	X
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globalce-157	282	3	]	]	X
globalce-157	282	4	.	.	PUNCT
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globalce-157	283	1	[	[	X
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globalce-157	283	7	.	.	PUNCT
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globalce-157	284	3	:	:	PUNCT
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globalce-157	286	1	[	[	X
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globalce-157	286	7	.	.	PUNCT
globalce-157	287	1	alerts	alert	NOUN
globalce-157	287	2	,	,	PUNCT
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globalce-157	287	6	information	information	NOUN
globalce-157	287	7	:	:	PUNCT
globalce-157	288	1	drugs	drug	NOUN
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globalce-157	288	7	from	from	ADP
globalce-157	288	8	:	:	PUNCT
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globalce-157	288	18	devices	device	NOUN
globalce-157	288	19	.	.	PUNCT
globalce-157	289	1	field	field	NOUN
globalce-157	289	2	corrective	corrective	ADJ
globalce-157	289	3	actions	action	NOUN
globalce-157	289	4	[	[	X
globalce-157	289	5	internet	internet	NOUN
globalce-157	289	6	]	]	PUNCT
globalce-157	289	7	.	.	PUNCT
globalce-157	290	1	[	[	X
globalce-157	290	2	cited	cite	VERB
globalce-157	290	3	2023	2023	NUM
globalce-157	290	4	apr	apr	NOUN
globalce-157	290	5	11	11	NUM
globalce-157	290	6	]	]	PUNCT
globalce-157	290	7	.	.	PUNCT
globalce-157	291	1	available	available	ADJ
globalce-157	291	2	from	from	ADP
globalce-157	291	3	:	:	PUNCT
globalce-157	291	4	https://www.bfarm.de/en/medicaldevices/tasks/risk-assessment-and-research/fieldcorrective-actions/_node.html	https://www.bfarm.de/en/medicaldevices/tasks/risk-assessment-and-research/fieldcorrective-actions/_node.html	PROPN
globalce-157	291	5	9	9	NUM
globalce-157	291	6	.	.	PUNCT
globalce-157	292	1	malataras	malataras	PROPN
globalce-157	293	1	p	p	X
globalce-157	293	2	,	,	PUNCT
globalce-157	293	3	pallikarakis	pallikarakis	PROPN
globalce-157	293	4	n.	n.	PROPN
globalce-157	293	5	spin	spin	VERB
globalce-157	293	6	-	-	PUNCT
globalce-157	293	7	off	off	ADP
globalce-157	293	8	use	use	NOUN
globalce-157	293	9	of	of	ADP
globalce-157	293	10	adverse	adverse	ADJ
globalce-157	293	11	events	event	NOUN
globalce-157	293	12	data	datum	NOUN
globalce-157	293	13	:	:	PUNCT
globalce-157	293	14	why	why	SCONJ
globalce-157	293	15	and	and	CCONJ
globalce-157	293	16	how	how	SCONJ
globalce-157	293	17	.	.	PUNCT
globalce-157	294	1	the	the	DET
globalce-157	294	2	case	case	NOUN
globalce-157	294	3	of	of	ADP
globalce-157	294	4	fda	fda	PROPN
globalce-157	294	5	’s	’s	PART
globalce-157	294	6	maude	maude	PROPN
globalce-157	294	7	.	.	PUNCT
globalce-157	295	1	global	global	PROPN
globalce-157	295	2	ce	ce	PROPN
globalce-157	295	3	j.	j.	PROPN
globalce-157	295	4	2018;1(1):9–23	2018;1(1):9–23	PROPN
globalce-157	295	5	.	.	PROPN
globalce-157	296	1	10	10	NUM
globalce-157	296	2	.	.	X
globalce-157	297	1	rayess	rayess	PROPN
globalce-157	297	2	hm	hm	INTJ
globalce-157	297	3	,	,	PUNCT
globalce-157	297	4	svider	svider	PROPN
globalce-157	297	5	pf	pf	PROPN
globalce-157	297	6	,	,	PUNCT
globalce-157	297	7	hanba	hanba	PROPN
globalce-157	297	8	c	c	X
globalce-157	297	9	,	,	PUNCT
globalce-157	297	10	patel	patel	PROPN
globalce-157	297	11	vs	vs	ADP
globalce-157	297	12	,	,	PUNCT
globalce-157	297	13	dejoseph	dejoseph	PROPN
globalce-157	297	14	lm	lm	PROPN
globalce-157	297	15	,	,	PUNCT
globalce-157	297	16	carron	carron	PROPN
globalce-157	297	17	m	m	PROPN
globalce-157	297	18	,	,	PUNCT
globalce-157	297	19	et	et	PROPN
globalce-157	297	20	al	al	PROPN
globalce-157	297	21	.	.	PUNCT
globalce-157	298	1	a	a	DET
globalce-157	298	2	cross	cross	ADJ
globalce-157	298	3	-	-	ADJ
globalce-157	298	4	sectional	sectional	ADJ
globalce-157	298	5	analysis	analysis	NOUN
globalce-157	298	6	of	of	ADP
globalce-157	298	7	adverse	adverse	ADJ
globalce-157	298	8	events	event	NOUN
globalce-157	298	9	and	and	CCONJ
globalce-157	298	10	litigation	litigation	NOUN
globalce-157	298	11	for	for	ADP
globalce-157	298	12	injectable	injectable	ADJ
globalce-157	298	13	fillers	filler	NOUN
globalce-157	298	14	.	.	PUNCT
globalce-157	299	1	jama	jama	PROPN
globalce-157	299	2	facial	facial	ADJ
globalce-157	299	3	plast	plast	NOUN
globalce-157	299	4	surg	surg	NOUN
globalce-157	299	5	.	.	PUNCT
globalce-157	300	1	2018	2018	NUM
globalce-157	300	2	may	may	AUX
globalce-157	300	3	1;20(3):207–14	1;20(3):207–14	NUM
globalce-157	300	4	.	.	PUNCT
globalce-157	301	1	11	11	NUM
globalce-157	301	2	.	.	PUNCT
globalce-157	302	1	rahimpour	rahimpour	PROPN
globalce-157	302	2	s	s	PART
globalce-157	302	3	,	,	PUNCT
globalce-157	302	4	kiyani	kiyani	PROPN
globalce-157	302	5	m	m	PROPN
globalce-157	302	6	,	,	PUNCT
globalce-157	302	7	hodges	hodges	PROPN
globalce-157	302	8	se	se	PROPN
globalce-157	302	9	,	,	PUNCT
globalce-157	302	10	turner	turner	PROPN
globalce-157	302	11	da	da	PROPN
globalce-157	302	12	.	.	PUNCT
globalce-157	303	1	deep	deep	ADJ
globalce-157	303	2	brain	brain	NOUN
globalce-157	303	3	stimulation	stimulation	NOUN
globalce-157	303	4	and	and	CCONJ
globalce-157	303	5	electromagnetic	electromagnetic	ADJ
globalce-157	303	6	interference	interference	NOUN
globalce-157	303	7	.	.	PUNCT
globalce-157	304	1	clin	clin	PROPN
globalce-157	304	2	neurol	neurol	PROPN
globalce-157	304	3	neurosurg	neurosurg	PROPN
globalce-157	304	4	.	.	PUNCT
globalce-157	305	1	2021	2021	NUM
globalce-157	305	2	apr;203:106577	apr;203:106577	PROPN
globalce-157	305	3	.	.	PUNCT
globalce-157	306	1	12	12	NUM
globalce-157	306	2	.	.	PUNCT
globalce-157	307	1	carey	carey	PROPN
globalce-157	307	2	j	j	PROPN
globalce-157	307	3	,	,	PUNCT
globalce-157	307	4	gabbireddy	gabbireddy	PROPN
globalce-157	307	5	s	s	PROPN
globalce-157	307	6	,	,	PUNCT
globalce-157	307	7	mammen	mammen	ADJ
globalce-157	307	8	l	l	NOUN
globalce-157	307	9	,	,	PUNCT
globalce-157	307	10	rosamilia	rosamilia	VERB
globalce-157	307	11	g	g	PROPN
globalce-157	307	12	,	,	PUNCT
globalce-157	307	13	patel	patel	PROPN
globalce-157	307	14	v	v	PROPN
globalce-157	307	15	,	,	PUNCT
globalce-157	307	16	foyt	foyt	PROPN
globalce-157	307	17	d	d	PROPN
globalce-157	307	18	,	,	PUNCT
globalce-157	307	19	et	et	PROPN
globalce-157	307	20	al	al	PROPN
globalce-157	307	21	.	.	PROPN
globalce-157	308	1	fda	fda	PROPN
globalce-157	308	2	maude	maude	PROPN
globalce-157	308	3	database	database	PROPN
globalce-157	308	4	analysis	analysis	NOUN
globalce-157	308	5	of	of	ADP
globalce-157	308	6	titanium	titanium	NOUN
globalce-157	308	7	middle	middle	ADJ
globalce-157	308	8	ear	ear	NOUN
globalce-157	308	9	prosthesis	prosthesis	NOUN
globalce-157	308	10	.	.	PUNCT
globalce-157	309	1	j	j	PROPN
globalce-157	309	2	otol	otol	NOUN
globalce-157	309	3	.	.	PUNCT
globalce-157	310	1	2022	2022	NUM
globalce-157	310	2	jan;17(1):18–24	jan;17(1):18–24	NOUN
globalce-157	310	3	.	.	PUNCT
globalce-157	311	1	13	13	NUM
globalce-157	311	2	.	.	X
globalce-157	311	3	tong	tong	PROPN
globalce-157	311	4	jy	jy	PROPN
globalce-157	311	5	,	,	PUNCT
globalce-157	311	6	pasick	pasick	PROPN
globalce-157	311	7	lj	lj	PROPN
globalce-157	311	8	,	,	PUNCT
globalce-157	311	9	benito	benito	PROPN
globalce-157	311	10	da	da	PROPN
globalce-157	311	11	,	,	PUNCT
globalce-157	311	12	monfared	monfare	VERB
globalce-157	311	13	a	a	PRON
globalce-157	311	14	,	,	PUNCT
globalce-157	311	15	sataloff	sataloff	PROPN
globalce-157	312	1	rt	rt	PROPN
globalce-157	312	2	.	.	PROPN
globalce-157	312	3	adverse	adverse	ADJ
globalce-157	312	4	events	event	NOUN
globalce-157	312	5	associated	associate	VERB
globalce-157	312	6	with	with	ADP
globalce-157	312	7	ossicular	ossicular	ADJ
globalce-157	312	8	prostheses	prosthesis	NOUN
globalce-157	312	9	:	:	PUNCT
globalce-157	312	10	utility	utility	NOUN
globalce-157	312	11	of	of	ADP
globalce-157	312	12	a	a	DET
globalce-157	312	13	federal	federal	ADJ
globalce-157	312	14	database	database	NOUN
globalce-157	312	15	.	.	PUNCT
globalce-157	313	1	otol	otol	PROPN
globalce-157	313	2	neurotol	neurotol	PROPN
globalce-157	313	3	.	.	PUNCT
globalce-157	314	1	2022	2022	NUM
globalce-157	314	2	feb	feb	PROPN
globalce-157	314	3	1;43(2):e229–34	1;43(2):e229–34	PROPN
globalce-157	314	4	.	.	PUNCT
globalce-157	315	1	14	14	NUM
globalce-157	315	2	.	.	PUNCT
globalce-157	316	1	alhusain	alhusain	PROPN
globalce-157	316	2	r	r	PROPN
globalce-157	316	3	,	,	PUNCT
globalce-157	316	4	dayco	dayco	PROPN
globalce-157	316	5	j	j	PROPN
globalce-157	316	6	,	,	PUNCT
globalce-157	316	7	awadelkarim	awadelkarim	VERB
globalce-157	316	8	a	a	PRON
globalce-157	316	9	,	,	PUNCT
globalce-157	316	10	almas	almas	PROPN
globalce-157	316	11	t	t	PROPN
globalce-157	316	12	,	,	PUNCT
globalce-157	316	13	halboni	halboni	PROPN
globalce-157	316	14	a	a	PROPN
globalce-157	316	15	,	,	PUNCT
globalce-157	316	16	ahmed	ahmed	PROPN
globalce-157	316	17	ak	ak	PROPN
globalce-157	316	18	,	,	PUNCT
globalce-157	316	19	et	et	PROPN
globalce-157	316	20	al	al	PROPN
globalce-157	316	21	.	.	PROPN
globalce-157	317	1	turnpike	turnpike	PROPN
globalce-157	317	2	catheter	catheter	NOUN
globalce-157	317	3	failure	failure	NOUN
globalce-157	317	4	,	,	PUNCT
globalce-157	317	5	causes	cause	NOUN
globalce-157	317	6	and	and	CCONJ
globalce-157	317	7	mechanisms	mechanism	NOUN
globalce-157	317	8	:	:	PUNCT
globalce-157	318	1	insights	insight	NOUN
globalce-157	318	2	from	from	ADP
globalce-157	318	3	the	the	DET
globalce-157	318	4	maude	maude	PROPN
globalce-157	318	5	database	database	NOUN
globalce-157	318	6	.	.	PUNCT
globalce-157	319	1	ann	ann	PROPN
globalce-157	319	2	med	med	PROPN
globalce-157	319	3	surg	surg	PROPN
globalce-157	319	4	(	(	PUNCT
globalce-157	319	5	lond	lond	PROPN
globalce-157	319	6	)	)	PUNCT
globalce-157	319	7	.	.	PUNCT
globalce-157	320	1	2022	2022	NUM
globalce-157	320	2	jun;78:103923	jun;78:103923	NOUN
globalce-157	320	3	.	.	PUNCT
globalce-157	321	1	15	15	NUM
globalce-157	321	2	.	.	PUNCT
globalce-157	321	3	ensign	ensign	PROPN
globalce-157	321	4	lg	lg	PROPN
globalce-157	321	5	,	,	PUNCT
globalce-157	321	6	cohen	cohen	PROPN
globalce-157	321	7	kb	kb	PROPN
globalce-157	321	8	.	.	PUNCT
globalce-157	322	1	a	a	DET
globalce-157	322	2	primer	primer	NOUN
globalce-157	322	3	to	to	ADP
globalce-157	322	4	the	the	DET
globalce-157	322	5	structure	structure	NOUN
globalce-157	322	6	,	,	PUNCT
globalce-157	322	7	content	content	NOUN
globalce-157	322	8	and	and	CCONJ
globalce-157	322	9	linkage	linkage	NOUN
globalce-157	322	10	of	of	ADP
globalce-157	322	11	the	the	DET
globalce-157	322	12	fda	fda	PROPN
globalce-157	322	13	’s	’s	PART
globalce-157	322	14	manufacturer	manufacturer	NOUN
globalce-157	322	15	and	and	CCONJ
globalce-157	322	16	user	user	NOUN
globalce-157	322	17	facility	facility	NOUN
globalce-157	322	18	device	device	NOUN
globalce-157	322	19	experience	experience	NOUN
globalce-157	322	20	(	(	PUNCT
globalce-157	322	21	maude	maude	NOUN
globalce-157	322	22	)	)	PUNCT
globalce-157	322	23	files	file	NOUN
globalce-157	322	24	.	.	PUNCT
globalce-157	323	1	egems	egem	NOUN
globalce-157	323	2	(	(	PUNCT
globalce-157	323	3	wash	wash	VERB
globalce-157	323	4	dc	dc	PROPN
globalce-157	323	5	)	)	PUNCT
globalce-157	323	6	.	.	PUNCT
globalce-157	324	1	5(1):12	5(1):12	NUM
globalce-157	324	2	.	.	PUNCT
globalce-157	324	3	16	16	NUM
globalce-157	324	4	.	.	PUNCT
globalce-157	325	1	kavanagh	kavanagh	PROPN
globalce-157	325	2	kt	kt	PROPN
globalce-157	325	3	,	,	PUNCT
globalce-157	325	4	brown	brown	PROPN
globalce-157	325	5	re	re	PROPN
globalce-157	325	6	,	,	PUNCT
globalce-157	325	7	kraman	kraman	PROPN
globalce-157	325	8	ss	ss	PROPN
globalce-157	325	9	,	,	PUNCT
globalce-157	325	10	calderon	calderon	PROPN
globalce-157	325	11	le	le	PROPN
globalce-157	325	12	,	,	PUNCT
globalce-157	325	13	kavanagh	kavanagh	PROPN
globalce-157	325	14	sp	sp	PROPN
globalce-157	325	15	.	.	PROPN
globalce-157	325	16	reporter	reporter	NOUN
globalce-157	325	17	’s	’s	PART
globalce-157	325	18	occupation	occupation	NOUN
globalce-157	325	19	and	and	CCONJ
globalce-157	325	20	source	source	NOUN
globalce-157	325	21	of	of	ADP
globalce-157	325	22	adverse	adverse	ADJ
globalce-157	325	23	device	device	NOUN
globalce-157	325	24	event	event	NOUN
globalce-157	325	25	reports	report	NOUN
globalce-157	325	26	contained	contain	VERB
globalce-157	325	27	in	in	ADP
globalce-157	325	28	the	the	DET
globalce-157	325	29	fda	fda	PROPN
globalce-157	325	30	’s	’s	PROPN
globalce-157	325	31	maude	maude	PROPN
globalce-157	325	32	database	database	PROPN
globalce-157	325	33	.	.	PUNCT
globalce-157	326	1	patient	patient	ADJ
globalce-157	326	2	relat	relat	PROPN
globalce-157	326	3	outcome	outcome	NOUN
globalce-157	326	4	meas	mea	NOUN
globalce-157	326	5	.	.	PUNCT
globalce-157	327	1	2019	2019	NUM
globalce-157	327	2	jul	jul	PROPN
globalce-157	327	3	2;10:205–8	2;10:205–8	NUM
globalce-157	327	4	.	.	PUNCT
globalce-157	327	5	17	17	NUM
globalce-157	327	6	.	.	PUNCT
globalce-157	328	1	connor	connor	PROPN
globalce-157	328	2	mj	mj	PROPN
globalce-157	328	3	,	,	PUNCT
globalce-157	328	4	tringale	tringale	PROPN
globalce-157	328	5	k	k	PROPN
globalce-157	328	6	,	,	PUNCT
globalce-157	328	7	moiseenko	moiseenko	PROPN
globalce-157	328	8	v	v	PROPN
globalce-157	328	9	,	,	PUNCT
globalce-157	328	10	marshall	marshall	PROPN
globalce-157	328	11	dc	dc	PROPN
globalce-157	328	12	,	,	PUNCT
globalce-157	328	13	moore	moore	PROPN
globalce-157	328	14	k	k	PROPN
globalce-157	328	15	,	,	PUNCT
globalce-157	328	16	cervino	cervino	PROPN
globalce-157	328	17	l	l	PROPN
globalce-157	328	18	,	,	PUNCT
globalce-157	328	19	et	et	PROPN
globalce-157	328	20	al	al	PROPN
globalce-157	328	21	.	.	PUNCT
globalce-157	329	1	medical	medical	ADJ
globalce-157	329	2	device	device	NOUN
globalce-157	329	3	recalls	recall	VERB
globalce-157	329	4	in	in	ADP
globalce-157	329	5	radiation	radiation	NOUN
globalce-157	329	6	oncology	oncology	NOUN
globalce-157	329	7	:	:	PUNCT
globalce-157	329	8	analysis	analysis	NOUN
globalce-157	329	9	of	of	ADP
globalce-157	329	10	u.s	u.s	PROPN
globalce-157	329	11	.	.	PROPN
globalce-157	329	12	food	food	PROPN
globalce-157	329	13	and	and	CCONJ
globalce-157	329	14	drug	drug	PROPN
globalce-157	329	15	administration	administration	PROPN
globalce-157	329	16	data	datum	NOUN
globalce-157	329	17	,	,	PUNCT
globalce-157	329	18	2002–2015	2002–2015	NUM
globalce-157	329	19	.	.	PUNCT
globalce-157	330	1	int	int	NOUN
globalce-157	330	2	j	j	PROPN
globalce-157	330	3	radiat	radiat	PROPN
globalce-157	330	4	oncol	oncol	ADJ
globalce-157	330	5	biol	biol	PROPN
globalce-157	330	6	phys	phy	NOUN
globalce-157	330	7	.	.	PUNCT
globalce-157	331	1	2017	2017	NUM
globalce-157	331	2	jun	jun	PROPN
globalce-157	331	3	1;98(2):438–46	1;98(2):438–46	NOUN
globalce-157	331	4	.	.	PUNCT
globalce-157	332	1	18	18	NUM
globalce-157	332	2	.	.	PUNCT
globalce-157	333	1	bitar	bitar	PROPN
globalce-157	333	2	c	c	PROPN
globalce-157	333	3	,	,	PUNCT
globalce-157	333	4	krupic	krupic	NOUN
globalce-157	333	5	f	f	PROPN
globalce-157	333	6	,	,	PUNCT
globalce-157	333	7	felländer	felländer	NOUN
globalce-157	333	8	-	-	PUNCT
globalce-157	333	9	tsai	tsai	PROPN
globalce-157	333	10	l	l	PROPN
globalce-157	333	11	,	,	PUNCT
globalce-157	333	12	crnalic	crnalic	PROPN
globalce-157	333	13	s	s	NOUN
globalce-157	333	14	,	,	PUNCT
globalce-157	333	15	wretenberg	wretenberg	PROPN
globalce-157	333	16	p.	p.	NOUN
globalce-157	333	17	living	live	VERB
globalce-157	333	18	with	with	ADP
globalce-157	333	19	a	a	DET
globalce-157	333	20	recalled	recall	VERB
globalce-157	333	21	implant	implant	NOUN
globalce-157	333	22	:	:	PUNCT
globalce-157	333	23	a	a	DET
globalce-157	333	24	qualitative	qualitative	ADJ
globalce-157	333	25	study	study	NOUN
globalce-157	333	26	of	of	ADP
globalce-157	333	27	patients	patient	NOUN
globalce-157	333	28	’	'	PUNCT
globalce-157	333	29	experiences	experience	NOUN
globalce-157	333	30	with	with	ADP
globalce-157	333	31	asr	asr	PROPN
globalce-157	333	32	hip	hip	NOUN
globalce-157	333	33	resurfacing	resurface	VERB
globalce-157	333	34	arthroplasty	arthroplasty	NOUN
globalce-157	333	35	.	.	PUNCT
globalce-157	334	1	patient	patient	ADJ
globalce-157	334	2	safety	safety	NOUN
globalce-157	334	3	in	in	ADP
globalce-157	334	4	surgery	surgery	NOUN
globalce-157	334	5	.	.	PUNCT
globalce-157	335	1	2021	2021	NUM
globalce-157	335	2	jan	jan	PROPN
globalce-157	335	3	6;15(1):2	6;15(1):2	NUM
globalce-157	335	4	.	.	PUNCT
globalce-157	336	1	19	19	NUM
globalce-157	336	2	.	.	NOUN
globalce-157	336	3	drugwatch	drugwatch	NOUN
globalce-157	336	4	.	.	PUNCT
globalce-157	337	1	drugwatch.com	drugwatch.com	X
globalce-157	337	2	.	.	PUNCT
globalce-157	338	1	[	[	X
globalce-157	338	2	cited	cite	VERB
globalce-157	338	3	2023	2023	NUM
globalce-157	338	4	apr	apr	NOUN
globalce-157	338	5	25	25	NUM
globalce-157	338	6	]	]	PUNCT
globalce-157	338	7	.	.	PUNCT
globalce-157	339	1	hip	hip	PROPN
globalce-157	339	2	replacement	replacement	NOUN
globalce-157	339	3	recall	recall	NOUN
globalce-157	339	4	|	|	ADV
globalce-157	339	5	causes	cause	VERB
globalce-157	339	6	and	and	CCONJ
globalce-157	339	7	fda	fda	PROPN
globalce-157	339	8	information	information	NOUN
globalce-157	339	9	.	.	PUNCT
globalce-157	340	1	available	available	ADJ
globalce-157	340	2	from	from	ADP
globalce-157	340	3	:	:	PUNCT
globalce-157	340	4	https://www.drugwatch.com/	https://www.drugwatch.com/	ADJ
globalce-157	340	5	hip	hip	NOUN
globalce-157	340	6	-	-	PUNCT
globalce-157	340	7	replacement	replacement	NOUN
globalce-157	340	8	/	/	SYM
globalce-157	340	9	recalls/	recalls/	NUM
globalce-157	340	10	20	20	NUM
globalce-157	340	11	.	.	PUNCT
globalce-157	341	1	fda	fda	PROPN
globalce-157	341	2	.	.	PUNCT
globalce-157	342	1	federal	federal	PROPN
globalce-157	342	2	register	register	PROPN
globalce-157	342	3	.	.	PUNCT
globalce-157	343	1	2014	2014	NUM
globalce-157	344	1	[	[	X
globalce-157	344	2	cited	cite	VERB
globalce-157	344	3	2023	2023	NUM
globalce-157	344	4	may	may	NOUN
globalce-157	344	5	3	3	NUM
globalce-157	344	6	]	]	PUNCT
globalce-157	344	7	.	.	PUNCT
globalce-157	345	1	medical	medical	ADJ
globalce-157	345	2	device	device	NOUN
globalce-157	345	3	reporting	reporting	NOUN
globalce-157	345	4	:	:	PUNCT
globalce-157	345	5	electronic	electronic	ADJ
globalce-157	345	6	submission	submission	NOUN
globalce-157	345	7	requirements	requirement	NOUN
globalce-157	345	8	.	.	PUNCT
globalce-157	346	1	available	available	ADJ
globalce-157	346	2	from	from	ADP
globalce-157	346	3	:	:	PUNCT
globalce-157	346	4	https://www.federalregister	https://www.federalregister	PROPN
globalce-157	346	5	.	.	PUNCT
globalce-157	347	1	gov	gov	PROPN
globalce-157	347	2	/	/	SYM
globalce-157	347	3	documents/2014/02/14/2014	documents/2014/02/14/2014	NOUN
globalce-157	347	4	-	-	PUNCT
globalce-157	347	5	03279	03279	NUM
globalce-157	347	6	/	/	SYM
globalce-157	347	7	medicaldevice	medicaldevice	NOUN
globalce-157	347	8	-	-	PUNCT
globalce-157	347	9	reporting	reporting	NOUN
globalce-157	347	10	-	-	PUNCT
globalce-157	347	11	electronic	electronic	ADJ
globalce-157	347	12	-	-	PUNCT
globalce-157	347	13	submission	submission	NOUN
globalce-157	347	14	-	-	PUNCT
globalce-157	347	15	requirements	requirement	NOUN
globalce-157	347	16	21	21	NUM
globalce-157	347	17	.	.	PUNCT
globalce-157	348	1	zuckerman	zuckerman	PROPN
globalce-157	348	2	dm	dm	PROPN
globalce-157	348	3	,	,	PUNCT
globalce-157	348	4	brown	brown	ADJ
globalce-157	348	5	p	p	NOUN
globalce-157	348	6	,	,	PUNCT
globalce-157	348	7	nissen	nissen	PROPN
globalce-157	348	8	se	se	X
globalce-157	348	9	.	.	PUNCT
globalce-157	349	1	medical	medical	ADJ
globalce-157	349	2	device	device	NOUN
globalce-157	349	3	recalls	recall	VERB
globalce-157	349	4	and	and	CCONJ
globalce-157	349	5	the	the	DET
globalce-157	349	6	fda	fda	PROPN
globalce-157	349	7	approval	approval	NOUN
globalce-157	349	8	process	process	NOUN
globalce-157	349	9	.	.	PUNCT
globalce-157	350	1	archives	archive	NOUN
globalce-157	350	2	of	of	ADP
globalce-157	350	3	internal	internal	ADJ
globalce-157	350	4	medicine	medicine	NOUN
globalce-157	350	5	.	.	PUNCT
globalce-157	351	1	2011	2011	NUM
globalce-157	351	2	jun	jun	PROPN
globalce-157	351	3	13;171(11):1006–11	13;171(11):1006–11	NUM
globalce-157	351	4	.	.	PUNCT
globalce-157	352	1	22	22	NUM
globalce-157	352	2	.	.	PUNCT
globalce-157	353	1	dubin	dubin	PROPN
globalce-157	353	2	jr	jr	PROPN
globalce-157	353	3	,	,	PUNCT
globalce-157	353	4	simon	simon	PROPN
globalce-157	353	5	sd	sd	PROPN
globalce-157	353	6	,	,	PUNCT
globalce-157	353	7	norrell	norrell	ADV
globalce-157	353	8	k	k	NOUN
globalce-157	353	9	,	,	PUNCT
globalce-157	353	10	perera	perera	PROPN
globalce-157	353	11	j	j	PROPN
globalce-157	353	12	,	,	PUNCT
globalce-157	353	13	gowen	gowen	PROPN
globalce-157	353	14	j	j	PROPN
globalce-157	353	15	,	,	PUNCT
globalce-157	353	16	cil	cil	ADJ
globalce-157	353	17	a.	a.	NOUN
globalce-157	353	18	risk	risk	NOUN
globalce-157	353	19	of	of	ADP
globalce-157	353	20	recall	recall	NOUN
globalce-157	353	21	among	among	ADP
globalce-157	353	22	medical	medical	ADJ
globalce-157	353	23	devices	device	NOUN
globalce-157	353	24	undergoing	undergo	VERB
globalce-157	353	25	us	we	PRON
globalce-157	353	26	food	food	NOUN
globalce-157	353	27	and	and	CCONJ
globalce-157	353	28	drug	drug	PROPN
globalce-157	353	29	administration	administration	NOUN
globalce-157	353	30	510(k	510(k	NUM
globalce-157	353	31	)	)	PUNCT
globalce-157	353	32	clearance	clearance	NOUN
globalce-157	353	33	and	and	CCONJ
globalce-157	353	34	premarket	premarket	NOUN
globalce-157	353	35	approval	approval	NOUN
globalce-157	353	36	,	,	PUNCT
globalce-157	353	37	2008	2008	NUM
globalce-157	353	38	-	-	SYM
globalce-157	353	39	2017	2017	NUM
globalce-157	353	40	.	.	PUNCT
globalce-157	354	1	jama	jama	PROPN
globalce-157	354	2	netw	netw	PROPN
globalce-157	354	3	open	open	ADJ
globalce-157	354	4	.	.	PUNCT
globalce-157	355	1	2021	2021	NUM
globalce-157	355	2	may	may	PROPN
globalce-157	355	3	3;4(5):e217274	3;4(5):e217274	NUM
globalce-157	355	4	.	.	PROPN
globalce-157	355	5	23	23	NUM
globalce-157	355	6	.	.	PUNCT
globalce-157	356	1	fda	fda	PROPN
globalce-157	357	1	[	[	X
globalce-157	357	2	internet	internet	NOUN
globalce-157	357	3	]	]	PUNCT
globalce-157	357	4	.	.	PUNCT
globalce-157	358	1	fda	fda	PROPN
globalce-157	358	2	;	;	PUNCT
globalce-157	358	3	2023	2023	NUM
globalce-157	359	1	[	[	PUNCT
globalce-157	359	2	cited	cite	VERB
globalce-157	359	3	2023	2023	NUM
globalce-157	359	4	oct	oct	NOUN
globalce-157	359	5	5	5	NUM
globalce-157	359	6	]	]	PUNCT
globalce-157	359	7	.	.	PUNCT
globalce-157	360	1	examples	example	NOUN
globalce-157	360	2	of	of	ADP
globalce-157	360	3	reported	report	VERB
globalce-157	360	4	infusion	infusion	NOUN
globalce-157	360	5	pump	pump	NOUN
globalce-157	360	6	problems	problem	NOUN
globalce-157	360	7	.	.	PUNCT
globalce-157	361	1	available	available	ADJ
globalce-157	361	2	from	from	ADP
globalce-157	361	3	:	:	PUNCT
globalce-157	361	4	https://www.fda.gov/medical-devices/infusion-pumps/	https://www.fda.gov/medical-devices/infusion-pumps/	PROPN
globalce-157	361	5	examples	example	NOUN
globalce-157	361	6	-	-	PUNCT
globalce-157	361	7	reported	report	VERB
globalce-157	361	8	-	-	PUNCT
globalce-157	361	9	infusion	infusion	NOUN
globalce-157	361	10	-	-	PUNCT
globalce-157	361	11	pump	pump	NOUN
globalce-157	361	12	-	-	PUNCT
globalce-157	361	13	problems	problem	NOUN
globalce-157	361	14	24	24	NUM
globalce-157	361	15	.	.	PUNCT
globalce-157	362	1	craig	craig	PROPN
globalce-157	362	2	a	a	PROPN
globalce-157	362	3	,	,	PUNCT
globalce-157	362	4	o’meley	o’meley	PROPN
globalce-157	362	5	p	p	X
globalce-157	362	6	,	,	PUNCT
globalce-157	362	7	carter	carter	PROPN
globalce-157	362	8	p.	p.	PROPN
globalce-157	362	9	the	the	DET
globalce-157	362	10	need	need	NOUN
globalce-157	362	11	for	for	ADP
globalce-157	362	12	greater	great	ADJ
globalce-157	362	13	reporting	reporting	NOUN
globalce-157	362	14	of	of	ADP
globalce-157	362	15	medical	medical	ADJ
globalce-157	362	16	device	device	NOUN
globalce-157	362	17	incidents	incident	NOUN
globalce-157	362	18	.	.	PUNCT
globalce-157	363	1	emj	emj	INTJ
globalce-157	363	2	.	.	PROPN
globalce-157	363	3	2019	2019	NUM
globalce-157	363	4	oct	oct	PROPN
globalce-157	363	5	1;3(1):56–63	1;3(1):56–63	PROPN
globalce-157	363	6	.	.	PROPN
globalce-157	363	7	25	25	NUM
globalce-157	363	8	.	.	X
globalce-157	364	1	2knisely	2knisely	NUM
globalce-157	364	2	bm	bm	PROPN
globalce-157	364	3	,	,	PUNCT
globalce-157	364	4	levine	levine	PROPN
globalce-157	364	5	c	c	PROPN
globalce-157	364	6	,	,	PUNCT
globalce-157	364	7	kharod	kharod	PROPN
globalce-157	364	8	kc	kc	PROPN
globalce-157	364	9	,	,	PUNCT
globalce-157	364	10	vaughn	vaughn	PROPN
globalce-157	364	11	-	-	PUNCT
globalce-157	364	12	cooke	cooke	PROPN
globalce-157	364	13	m.	m.	NOUN
globalce-157	364	14	an	an	DET
globalce-157	364	15	analysis	analysis	NOUN
globalce-157	364	16	of	of	ADP
globalce-157	364	17	fda	fda	PROPN
globalce-157	364	18	adverse	adverse	ADJ
globalce-157	364	19	event	event	NOUN
globalce-157	364	20	reporting	report	VERB
globalce-157	364	21	data	datum	NOUN
globalce-157	364	22	for	for	ADP
globalce-157	364	23	trends	trend	NOUN
globalce-157	364	24	in	in	ADP
globalce-157	364	25	medical	medical	ADJ
globalce-157	364	26	device	device	NOUN
globalce-157	364	27	use	use	NOUN
globalce-157	364	28	error	error	NOUN
globalce-157	364	29	.	.	PUNCT
globalce-157	365	1	proceedings	proceeding	NOUN
globalce-157	365	2	of	of	ADP
globalce-157	365	3	the	the	DET
globalce-157	365	4	international	international	ADJ
globalce-157	365	5	symposium	symposium	NOUN
globalce-157	365	6	on	on	ADP
globalce-157	365	7	human	human	ADJ
globalce-157	365	8	factors	factor	NOUN
globalce-157	365	9	and	and	CCONJ
globalce-157	365	10	ergonomics	ergonomic	NOUN
globalce-157	365	11	in	in	ADP
globalce-157	365	12	health	health	NOUN
globalce-157	365	13	care	care	NOUN
globalce-157	365	14	.	.	PUNCT
globalce-157	366	1	2020	2020	NUM
globalce-157	366	2	sep	sep	PROPN
globalce-157	366	3	1;9(1):130–4	1;9(1):130–4	NUM
globalce-157	366	4	.	.	PUNCT
globalce-157	367	1	http://canada.ca	http://canada.ca	PROPN
globalce-157	367	2	https://recalls-rappels.canada.ca/en	https://recalls-rappels.canada.ca/en	PROPN
globalce-157	367	3	https://recalls-rappels.canada.ca/en	https://recalls-rappels.canada.ca/en	PROPN
globalce-157	367	4	http://mhra.gov.uk	http://mhra.gov.uk	NOUN
globalce-157	367	5	https://www.gov.uk/drug-device-alerts	https://www.gov.uk/drug-device-alert	VERB
globalce-157	367	6	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	PROPN
globalce-157	367	7	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	NUM
globalce-157	367	8	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html	PROPN
globalce-157	367	9	http://drugwatch.com	http://drugwatch.com	X
globalce-157	367	10	https://www.drugwatch.com/hip-replacement/recalls/	https://www.drugwatch.com/hip-replacement/recalls/	ADJ
globalce-157	367	11	https://www.drugwatch.com/hip-replacement/recalls/	https://www.drugwatch.com/hip-replacement/recalls/	VERB
globalce-157	367	12	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirement	NOUN
globalce-157	367	13	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirement	NOUN
globalce-157	367	14	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements	https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirement	NOUN
globalce-157	367	15	https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problems	https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problem	NOUN
globalce-157	367	16	https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problems	https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problem	VERB