BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD COMPOSIX KUGEL

    MDR report key: 710091 · Received April 6, 2006

    Report

    Report Number
    710091
    Event Type
    Injury
    Date Received
    April 6, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 6, 2006
    Manufacturer
    DAVOL INC., SUB. C. R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SURGERY AND HAD A DAVOL BARD COMPOSIX KUGEL MESH, LOT # 43FND006, IMPLANTED FOR HERNIA REPAIR. PATIENT RETURNED APPROXIMATELY 2 1/2 YEARS LATER, WITH BOWEL OBSTRUCTION AND RECURRENT HERNIA. MESH REMOVED BY SURGEON AND HERNIA REPAIRED. DURING PROCEDURE, SURGEON FOUND "RING" TO BE EXPOSED ON KUGEL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD COMPOSIX KUGEL MESH FTL DAVOL INC., SUB. C. R. BARD, INC. * 43FND006

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R