BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PROCEED VENTRAL PATCH

    MDR report key: 1905845 · Received November 16, 2010

    Report

    Report Number
    MW5018266
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    April 28, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ETHICON
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, UMBILICAL HERNIA REPAIR DONE UTILIZING ETHICON PROCEED VENTRAL PATCH. ON (B)(6) 2010, UMBILICAL HERNIA REAPPEARED BIGGER THEN EVER. THE PATCH FELT LIKE IT WAS BUNCHED UP AS OPPOSED TO LYING FLAT AS IT ORIGINALLY WAS POST OP. AFTER THAT, THE PATCH FELT AS IF IT WAS MIGRATING TO DIFFERENT PARTS OF THE AREA SURROUNDING MY BELLY BUTTON. ON (B)(6) 2010, UMBILICAL HERNIA WAS REPAIRED AFTER ETHICON PROCEED VENTRAL PATCH WAS REMOVED AND SENT TO PATHOLOGY. ETHICON PROCEED VENTRAL PATCH WAS NOT USED FOR THE REPAIR. INSTEAD, 3-4 INCH INCISION WAS MADE TO REMOVE DEFECTIVE PRODUCT AND THE MUSCLE AND SKIN WERE THEN SUTURED ELIMINATING MY BELLY BUTTON, BUT CREATING A SOLID REPAIR WITHOUT MESH. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON PROCEED VENTRAL PATCH PROCEED VENTRAL PATCH FTL ETHICON PVPM

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability