BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX KUGEL MESH PATCH

    MDR report key: 1241943 · Received November 17, 2008

    Report

    Report Number
    1241943
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 17, 2008
    Manufacturer
    DAVOL, INC. SUB. C.R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PARTIAL SMALL-BOWEL OBSTRUCTION SECONDARY TO ADHESIONS THAT CAUSED MULTIPLE HOSPITALIZATIONS. REQUIRED SURGERY. AT TIME OF SURGERY, DURING DISSECTION OF THE ADHESIONS TO THE ANTERIOR ABDOMINAL WALL, THE LEFT LATERAL INFERIOR PORTION OF THE PROSTHESIS WAS FOUND TO HAVE A FRACTURE OF THE SUPPORTING RING AT ITS PERIPHERY. THE PROSTHESIS WAS ADHERENT TO LOOPS OF SMALL BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL MESH PATCH MESH, SURGICAL HERNIA FTL DAVOL, INC. SUB. C.R. BARD, INC. * 43APD292

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R