BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3423250 · Received October 8, 2013

    Report

    Report Number
    3004859928-2013-00190
    Event Type
    Injury
    Date Received
    October 8, 2013
    Date of Event
    March 30, 2009
    Report Date
    October 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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 ON THE (B)(6) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) 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 FOLLOWING IMPLANT OF POLYFORM MESH PATIENT SUFFERED PAIN DUE TO ERODED MESH, ADDITIONAL MEDICAL TREATMENT AND PROCEDURES. THE DATE OF IMPLANT OF THE MESH IS (B)(6) 2009. 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) HOSPITAL, (B)(6), USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR (B)(6). THE IMPLANT INVOLVED IN THIS COMPLAINT IS A POLYFORM SYNTHETIC MESH - LOT NUMBER IS C000540 - EXPIRY DATE 31 JAN 2010, MANUFACTURING DATE 31 JULY 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509865 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD 10-15-CM C000540

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other