BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3600631 · Received January 16, 2014

    Report

    Report Number
    3004859928-2014-00003
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    March 9, 2010
    Report Date
    January 14, 2014
    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

    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 - REFER 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 (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2013 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REP. THE COMPLAINT STATES THAT FOLLOWING IMPLANT OF POLYFORM MESH THE PATIENT SUFFERED SERIOUS AN INJURY. THE DATE OF IMPLANT OF THE MESH IS (B)(6) 2010. THE PATIENT IS IDENTIFIED AS "KAB". HER DATE OF BIRTH IS UNK; HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6). THE PHYSICIAN WHO TREATED THE PATIENT IS (B)(6). THE PRODUCTION PART NUMBER AND LOT NUMBER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42812 POLYFORM SYNTHETIC MESH MESH SURGICAL POLYMERIC FTL PROXY BIOMEDICAL LTD. 10X15CM OR 15X20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other