FDA Adverse Event Injury Summary report: N

POLYFORM SYNTHETIC MESH

MDR report key: 2851190 · Received November 22, 2012

Report

Report Number: 3004859928-2012-00048
Event Type: Injury
Date Received: November 22, 2012
Date of Event: January 1, 2008
Report Date: November 22, 2012
Manufacturer: PROXY BIOMEDICAL LTD.
Product Code: FTL
PMA / PMN Number: K051245
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

EVAL METHOD CODE- DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION- INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS MESH EROSION, INFECTION, INCONTINENCE, ADHESION, FISTULA FORMATION AND PAIN 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) 2012 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(6)) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2012 REGARDING A POLYFORM PRODUCT FROM A PT¿S LEGAL REP. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT, A PT INJURY OCCURRED. THE DATE OF IMPLANTATION OF THE MESH WAS THE (B)(6) 2008. THE PT IS IDENTIFIED AS ¿(B)(6)¿; PATIENT IS FEMALE, HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSPITAL WHERE THE IMPLANT PROCEDURE OCCURRED IS THE (B)(6) HOSPITAL, USA. THE PHYSICIAN¿S NAME IS DR (B)(6). THE POLYFORM PRODUCT PART NUMBER AND LOT NUMBER ARE UNK. NO OTHER INFO REGARDING THE PRODUCT OR THE PT IS AVAILABLE AT THIS TIME.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other