MAUDE MDR 3487241

MDR report key: 3487241
Report number: 1018233-2013-08703
Event key: 0
Event type: 3
Date received: 2013-11-20
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: CHRISTY LEWIS
Address: 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone: 770-770-7708
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	UNKNOWN WOMEN'S HEALTH MESH PRODUCT	OTP, PAG	C.R. BARD, INC. (COVINGTON)	OTP	NA	UNK	UNK				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-11-20	0	1. R; 2. S

Event Narratives#

D

Patient 1

IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SERIOUS AND PERMANENT INJURIES, PAIN, DISFIGUREMENT, PHYSICAL IMPAIRMENT, PROGRESSION OF EXISTING CONDITIONS AND HAD REQUIRED AND WILL REQUIRE CONTINUED MEDICAL TREATMENT.

N

Patient 1

THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNKNOWN; THEREFORE, BARD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING AND DFMEA TO REVIEW. IF ADD'L INFO IS REC'D, A F/U WILL BE SUBMITTED. "LAWYER-FILED REPORT-(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 3487241

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#