BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 985566 · Received January 24, 2008

    Report

    Report Number
    1213643-2008-00179
    Event Type
    Injury
    Date Received
    January 24, 2008
    Date of Event
    October 1, 2007
    Report Date
    December 27, 2007
    Manufacturer
    DAVOL, INC., SUB C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO CONCLUSION CAN BE DRAWN. IF THE PRODUCT IS RETURNED OR MORE INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCARCERATED VENTRAL HERNIA REPAIR IN 2007, DURING WHICH THE SURGEON IMPLANTED GORE-TEX PROLENE SURGICAL MESH. NINE MONTHS LATER, THE PATIENT HAD SURGERY TO REMOVE THE INFECTED MESH. W.L. GORE & ASSOCIATES INC BECAME AWARE THE ACTUAL DEVICE INVOLVED A BARD COMPOSIX KUGEL PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL, INC., SUB C.R. BARD, INC. NA 43CQD281

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention