FDA Adverse Event Injury Summary report: N

POLYFORM SYNTHETIC MESH

MDR report key: 3163032 · Received May 28, 2013

Report

Report Number: 3004859928-2013-00049
Event Type: Injury
Date Received: May 28, 2013
Date of Event: May 3, 2007
Report Date: May 13, 2013
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

EVAL CODE: DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION CODE: 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 (B)(4) AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

Description of Event or Problem · 1

PROXY BIOMEDICAL WAS NOTIFIED ON (B)(4) 2013, VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(6) 2013, REGARDING A POLYFORM PRODUCT FROM A PT'S LEGAL REP. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT (DATE OF IMPLANTATION IS (B)(6) 2007), A PT INJURY OCCURRED. THE PT IS IDENTIFIED AS "(B)(6)". HER DATE OF BIRTH IS UNK; HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSP WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS THE (B)(6), USA. THE PHYSICIAN WHO TREATED THE PT IS DR. (B)(6). THE POLYFORM PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED. 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
232989	POLYFORM SYNTHETIC MESH	MESH SURGICAL, POLYMERIC (FTL)	OTO	PROXY BIOMEDICAL LTD.	10X15CM OR 15X20CM	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other