FDA Adverse Event Injury Summary report: N

POLYFORM SYNTHETIC MESH

MDR report key: 2820556 · Received October 10, 2012

Report

Report Number: 3004859928-2012-00032
Event Type: Injury
Date Received: October 10, 2012
Date of Event: October 13, 2009
Report Date: October 10, 2012
Manufacturer: PROXY BIOMEDICAL LTD.
Product Code: OTO
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. CONCLUSION: INCONCLUSIVE, INVESTIGATION ONGOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS MESH EROSION, INCONTINENCE, FISTULA FORMATION 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)(4)) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(6) 2012, REGARDING A POLYFORM PRODUCT. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT, A PATIENT INJURY OCCURRED. THE COMPLAINT WAS REPORTED TO (B)(4) VIA EMAIL ON (B)(6) 2012, FROM (B)(6), THE PATIENT'S ATTORNEY. THE PATIENT IS IDENTIFIED AS "(B)(6)"; HER DATE OF BIRTH IS UNKNOWN. HER WEIGHT AND HEIGHT ARE NOT PROVIDED. THE HOSPITAL WHERE THE IMPLANT PROCEDURE OCCURRED IS (B)(6). THE DATE OF IMPLANTATION OF THE MESH WAS (B)(6) 2009. IT IS UNKNOWN IF CORRECTIVE SURGERY TO REPAIR OR REMOVE THE IMPLANT TOOK PLACE. NO OTHER INFORMATION REGARDING THE PRODUCT OR THE PATIENT IS AVAILABLE AT THIS TIME. THE POLYFORM PRODUCT LOT NUMBER WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POLYFORM SYNTHETIC MESH	MESH SURGICAL, POLYMERIC (FTL)	OTO	PROXY BIOMEDICAL LTD.	840-240 OR 840-241	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other