BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSIX KUGEL

    MDR report key: 890302 · Received July 2, 2007

    Report

    Report Number
    890302
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 2, 2007
    Manufacturer
    DAVOL, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE MESH WAS PLACED PRIOR TO THE MANUFACTURING RECALL. THE PATIENT WAS BROUGHT IN FOR A BOWEL STRICTURE PROCEDURE AND THE MESH WAS IDENTIFIED DURING THE SURGERY. BECAUSE WE WERE AWARE THAT THIS MAY HAVE BEEN RECALLED MESH PRODUCT, WE CALLED DAVOL, INC./C.R. BARD AND THEY CONFIRMED THAT THIS IS A PIECE OF MESH THAT HAD BEEN RECALLED. IT WAS DECIDED THE MESH WOULD BE REMOVED JUST TO BE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX KUGEL MESH, SURGICAL FTL DAVOL, INC. 0010206 43APD431

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR