MAUDE MDR 112405

MDR report key: 112405
Report number: 1224675-1997-00042
Event key: 0
Event type: 3
Date of event: 1997-07-01
Date received: 1997-08-11
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	STARTER KIT, SIZE 3, 1213	RELIANCE	UROMED CORP.	MNG	SIZE 3	1213	0000000008	P9600		N	*	*

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1997-08-11	0	1. R

Event Narratives#

D

Patient 1

PT WAS DIAGNOSED WITH A DEVICE MIGRATION AFTER AN ULTRASOUND WAS PERFORMED ON 7/23/97.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K010365	MNG	ORTHO CONTROL FEMALE URINARY CONTROL DEVICE	Personal Products Co.	2001-04-30
510(k)	K983164	MNG	RESTORE (AKA RE/STOR)	Nebl, Inc.	1999-03-05
510(k)	K974600	MNG	UROMED PATCH	Uromed Corp.	1998-03-31
510(k)	K974645	MNG	FEMASSIST FLEXIBLE	Insight Medical Corp.	1998-02-12
510(k)	K971359	MNG	RESTORE (A.K.A. CAPSURE)	Nebl, Inc.	1997-11-14