BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX KUGEL MESH LARGE OVAL

    MDR report key: 1040344 · Received May 8, 2008

    Report

    Report Number
    MW5006786
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BARD/DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007, PATIENT HAD BARD COMPOSIX KUGEL LARGE OVAL IMPLANT PLACED DURING SURGERY. IN 2008, PATIENT RETURNED TO SURGEON WITH COMPLAINTS OF PAIN. PATIENT HAD MULTIPLE PENETRATING CORKSCREW DEVICES THAT CAUSED INJURIES INTO THE INTESTINES AND ABDOMINAL WALL. PATIENT HAD MULTIPLE ABDOMINAL WALL HERNIAS AND NECROTIZING ABDOMINAL WALL INFECTION. DATES OF USE: 2007 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX KUGEL MESH LARGE OVAL NONE FTL BARD/DAVOL KUGEL COMPOSIX MESH 43JQD602
    2 GRAFT SEPRAFILM 5X6 NONE MCN GENZYME KUGEL COMPOSIX MESH 07NP129

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S