BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX COMPOSITE

    MDR report key: 4222473 · Received October 6, 2014

    Report

    Report Number
    4222473
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    May 21, 2014
    Report Date
    October 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A MIDDLE AGED GENTLEMAN WITH END-STAGE RENAL DISEASE WHO HAS UNDERGONE MULTIPLE ABDOMINAL PROCEDURES INCLUDING HERNIA REPAIR APPROXIMATELY FIVE YEARS AGO WITH PARIETEX COMPOSITE MESH. HE HAS HAD A CHRONIC DRAINING SINUS FROM THE MID PORTION OF HIS MIDLINE INCISION. HE UNDERWENT A WOUND EXPLORATION APPROXIMATELY THREE YEARS AGO WHERE SOME FOREIGN MATERIAL WAS REMOVED, PRESUMABLY MESH. THE WOUND WAS CLOSED, BUT HE CONTINUED TO HAVE A CHRONIC DRAINING SINUS THAT DRAINED PURULENT MATERIAL ON A BASICALLY DAILY BASIS. THIS WAS CAUSING SIGNIFICANT COMPROMISE TO HIS QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622259 PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC FTL COVIDIEN * PJB00391

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR