BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA MESH 3DP PATCH

    MDR report key: 2163509 · Received July 13, 2011

    Report

    Report Number
    MW5021292
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    December 9, 2005
    Report Date
    July 13, 2011
    Manufacturer
    ETHICON (J + J)
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER SURGERY, PT EXPERIENCED MORE PAIN THAN EXPECTED. PAIN PROGRESSED TO DEBILITATING. PAIN IN LEGS, ABDOMEN AND SURGICAL SITE. IT FELT LIKE AN OPEN WOUND INSIDE AND SOMEONE WAS RUBBING SAND PAPER OR BARBED WIRE IN IT. PT COULD NOT SIT, STAND OR WALK AND LOST (B)(6). THIS ALL HAPPENED WITHIN 6 MONTHS OF IMPLANT. WHEN MESH WAS EXPLANTED, IT WAS FOUND TO BE EMBEDDED IN THE FEMORAL ARTERY AND IN SURROUNDING VEINS. IT WAS CRUMPLED INTO A BALL. IT HAD TO BE SNAPPED OFF. EIGHT WEEKS LATER, SYMPTOMS ARE SLOWLY IMPROVING. HOSPITAL CLAIMS THEY LOST LOT NUMBERS. LOST JOB, CAREER AND ALL MONEY. SPENT 5 1/2 YRS TRYING TO FIND OUT WHAT WAS GOING ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE HERNIA MESH 3DP PATCH PROLENE MESH SIZE M FTL ETHICON (J + J)

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R