MAUDE MDR 3642054

MDR report key: 3642054
Report number: 1018233-2014-00026
Event key: 0
Event type: 3
Date received: 2014-02-07
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#

Contact: KIM SHIRAH
Address: 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone: 770-770-7707
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	AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM		BARD SHANNON LIMITED	OTP	NA	UNKNOWN	UNK				N	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-02-07	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT POSTERIOR REPAIR AND TRANSOBTURATOR TAPE PLACEMENT APPROXIMATELY 7 YEARS AGO THE PATIENT THEN SUBSEQUENTLY BEGAN TO HAVE FOUL SMELLING DISCHARGE AND POSTERIOR VAGINAL WALL MESH EROSION. CONSERVATIVE MANAGEMENT WITH VAGINAL ESTROGEN WAS UNSUCCESSFUL SO THE PATIENT IS PURSUING SURGICAL MANAGEMENT.

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00814723020050	Elevate	ENDO PHARMACEUTICALS INC.	OTP	2015-10-24
00814723020067	Elevate	ENDO PHARMACEUTICALS INC.	OTP	2015-10-24
05708932459433	Exair	Coloplast A/S	OTP	2015-10-22
05708932459457	Exair	Coloplast A/S	OTP	2015-10-22
08714729839200	Uphold™ LITE	BOSTON SCIENTIFIC CORPORATION	OTP	2015-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K122459	OTP	PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM	Boston Scientific Corporation	2012-12-13
510(k)	K121612	OTP	ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION	American Medical Systems	2012-07-20
510(k)	K112842	OTP	AMS ELEVATE PC	American Medical Systems, Inc.	2011-10-25
510(k)	K103426	OTP	LITE PELVIC FLOOR REPAIR KITS	Boston Scientific Corp	2011-09-14
510(k)	K112386	OTP	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM	Coloplast Corp.	2011-09-08

MAUDE MDR 3642054

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#