FDA Adverse Event Injury Summary report: N

POLYFORM SYNTHETIC MESH

MDR report key: 3163023 · Received May 28, 2013

Report

Report Number: 3004859928-2013-00036
Event Type: Injury
Date Received: May 28, 2013
Date of Event: February 10, 2010
Report Date: May 13, 2013
Manufacturer: PROXY BIOMEDICAL LTD.
Product Code: FTL
PMA / PMN Number: K051245
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION - DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS PAIN, MESH EROSION, INFECTION, INCONTINENCE, FISTULA FORMATION AND DYSPAREUNIA ARE DOCUMENTED RISKS ASSOCIATED WITH THE POLYFORM DEVICE - REFERENCE DESIGN FMEA AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

Description of Event or Problem · 1

PROXY BIOMEDICAL WAS NOTIFIED (B)(6) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(6)) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2013 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT (DATE OF IMPLANTATION IS (B)(6) 2010), A PATIENT INJURY OCCURRED. THE PATIENT IS IDENTIFIED AS "(B)(6)." HER DATE OF BIRTH IS UNKNOWN; HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6). THE PHYSICIAN WHO TREATED THE PATIENT IS DR (B)(6). TWO ADDITIONAL DEVICES WERE IMPLANTED ON THE SAME DATE ((B)(6) 2010), HOWEVER NO INFORMATION WAS PROVIDED REGARDING THESE DEVICES. THE POLYFORM PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
232872	POLYFORM SYNTHETIC MESH	MESH SURGICAL, POLYMERIC (FTL)	FTL	PROXY BIOMEDICAL LTD.	10X15CM OR 15X20CM	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other