MAUDE MDR 341748

MDR report key: 341748
Report number: MW4003031
Event key: 0
Event type: 3
Date of event: 2001-05-15
Date received: 2001-07-05
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 0
Event location: 3

Manufacturer Contact#

Report source: P
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	LIFESTYLES PREMIUM	LUBRICATED CONDOMS WITH NONOXYNOL	ANSELL HEALTHCARE INC	LTZ	NA	NI	NI			N		*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2001-07-05	0

Event Narratives#

D

Patient 1

THE CONSUMER STATED THAT THREE OF THE TWELVE CONDOMS FROM THE BOX FAILED DURING USE. THEY APPEARED TO HAVE BEEN TOO THIN.