BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL COMPOSITIX KUGEL MESH

    MDR report key: 1618906 · Received February 24, 2010

    Report

    Report Number
    MW5014935
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 24, 2010
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HAD A DAVOL KUGEL COMPOSITIX MESH PLACED (B) (6) 2005. THIS WAS DONE LAPAROSCOPICALLY. MESH WAS MODEL #0010206, (B) (6). SIZE WAS 22.1X27.1 CM. PT DID WELL FOR YEARS UNTIL (B) (6) 2009, WHEN HE PRESENTED WITH AN ABDOMINAL INFECTION/ABSCESS OVER THE MESH. THIS OCCURRED AFTER AN EPISODE OF BRONCHITIS. MESH WAS REMOVED ON (B) (6) 2010. RINGS IN MESH HAD FRACTURED AND PERFORATED THE SMALL BOWEL. MESH REPLACED WITH BIOLOGIC MESH. PT IS DOING WELL WITH A SLOWLY HEALING WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL COMPOSITIX KUGEL MESH NONE FTL 0010206

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| S