BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMAFIX FIXATION SYSTEM

    MDR report key: 3151813 · Received June 3, 2013

    Report

    Report Number
    MW5030451
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BARD-DAVOL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERMATAKER MISFIRING DURING VENTRAL MESH INSERTION. PARTIALLY SEALING TO MESH/ABD WALL. SURGEON DR. LESLIE GO AND DR AR MILLER. WHEN USING THE PERMATACK TO AFFIX PATCH TO ABDOMINAL WALL, THE TACK WOULD NOT CONSISTENTLY SEAT PROPERLY. THE TACK WOULD PENETRATE THROUGH THE MESH/PATCH AND ONLY MINIMALLY INTO ABDOMINAL WALL DESPITE USE OF FIRM PRESSURE. THIS HAPPENED MULTIPLE TIMES EVENT WITH 2 DIFFERENT EXPERIENCED SURGEONS USING THE TACKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242943 PERMAFIX FIXATION SYSTEM PRMAFIX GDW BARD-DAVOL HUXC2067

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR