FDA Adverse Event Injury Summary report: N

POLYFORM SYNTHETIC MESH

MDR report key: 3861966 · Received May 2, 2014

Report

Report Number: 3004859928-2014-00048
Event Type: Injury
Date Received: May 2, 2014
Date of Event: September 30, 2008
Report Date: April 30, 2014
Manufacturer: PROXY BIOMEDICAL LTD.
Product Code: FTL
PMA / PMN Number: K051245
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION: DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM (B)(4). 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 ON THE (B)(4) 2014 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2014 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT FOLLOWING IMPLANT OF POLYFORM MESH THE PATIENT SUFFERED AN INJURY. THE DATE OF IMPLANT OF THE MESH IS(B)(6) 2008. THE PATIENT IS IDENTIFIED AS "(B)(6)". PATIENT'S DATE OF BIRTH IS UNKNOWN; HER WEIGHT AND HEIGHT DETAILS HAVE NOT BEEN PROVIDED. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS THE (B)(6), USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR (B)(6). THE IMPLANT INVOLVED IN THIS COMPLAINT IS A POLYFORM SYNTHETIC MESH - THE PART NUMBER IS A 10X15CM OR 10X20CM; THE LOT NUMBER IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
263777	POLYFORM SYNTHETIC MESH	MESH SURGICAL, POLYMERIC - FTL	FTL	PROXY BIOMEDICAL LTD.	10X15 OR 15X20CM	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other	UNKNOWN IF ANY