BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD-KUGEL

    MDR report key: 2163510 · Received July 6, 2011

    Report

    Report Number
    MW5021294
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    January 8, 2008
    Report Date
    July 6, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE LEFT ABDOMINAL MUSCLE AREA, JUST ABOVE AND TO THE LEFT OF THE MALE GROIN AREA WAS COVERED WITH A BARD-KUGEL MESH HERNIA DEVICE. THE SURGERY WAS TO CORRECT WEAKENED ABDOMINAL MUSCLE PROTRUSION OF THE INTESTINES. THE LEFT MESH SCREEN IS NOT TOTALLY FLAT, BUT HAS NOT CAUSED ANY COMPLICATIONS TO DATE. ON (B)(6) 2008, THE RIGHT ABDOMINAL MUSCLE AREA, JUST ABOVE AND TO THE RIGHT OF THE MALE GROIN AREA WAS COVERED WITH A BARD-KUGEL MESH HERNIA DEVICE. THE SURGERY WAS TO CORRECT WEAKENED ABDOMINAL MUSCLE PROTRUSION OF THE INTESTINES. THE RIGHT MESH SCREEN WAS NOT TOTALLY FLAT AFTER THE SURGERY, BUT IS CURRENTLY CAUSING NEUROLOGICAL COMPLICATIONS AND SKELETAL TENDERNESS SURROUNDING THE INCISION POINT AND HAS DEVELOPED AN EXTREMELY LARGE PROTRUSION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD-KUGEL HERNIA PATCH FTL C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Congenital Anomaly| H| L| O| S