BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX KUGEL HERNIA PATCH

    MDR report key: 1002849 · Received February 21, 2008

    Report

    Report Number
    MW5005653
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    October 23, 2007
    Report Date
    February 21, 2008
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SURGERY FOR HERNIA REPAIR IN WHICH THE KUGEL MESH PATCH WAS INSTALLED LOT #43LQD203. IT WAS A ONE DAY THING. ON TWO DAYS LATER, WE HAD TO CALL AN AMBULANCE & I WAS RE ADMITTED TO ALBERT EINSTEIN AS THE MESH BECAME INFECTED. ON FIVE DAYS LATER, I WAS OPERATED TO HAVE THE MESH REMOVED. THEY ALSO HAD TO PERFORM A SMALL BOWEL RESECTION WITH REPAIR OF THE FISTULA. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: INCISIONAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL HERNIA PATCH KUGEL HERNIA PATCH FTL BARD * 43LQD203

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| S