BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPT

    MDR report key: 2081824 · Received May 3, 2011

    Report

    Report Number
    MW5020505
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    July 30, 2010
    Report Date
    May 3, 2011
    Manufacturer
    HOLLISTER INCORPORATED CONSUMER PROGRAMS TEAMS
    Product Code
    EZR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE AN OSTOMY BAG WHICH I HAVE WORN FOR APPROXIMATELY 18 YEARS. IN THE (B)(6) 2010, I STARTED TO GET RED DOTS ON MY SKIN WHICH I ATTRIBUTED TO THE HEAT. AS TIME WENT ON, THE SKIN GOT REDDER AND THE TISSUE BEGAN TO SEEP FLUID TO THE POINT IN 2011, I COULD NOT WEAR THE BAG DUE TO EXCESSIVE SEEPING. I CONTACTED MY OSTOMY NURSE WHO TRIED DIFFERENT PRODUCTS TO THE POINT SHE WAS AT A LOSS. AT THAT POINT, I WENT TO A SURGEON WHO INITIALLY THOUGHT IT WAS MY CROHN'S ATTACKING MY SKIN. HE PUT ME ON A DOSE OF PREDNISONE AND THAT HELPED THE SKIN START TO CLEAR. ONCE I TAPERED OF THE PREDNISONE, THE WEEPING SKIN AND ULCERATIONS STARTED UP AGAIN. HE THEN PUT ME ON A LONG REGIMEN OF PREDNISONE AND HAD ME SLOWLY TAPER AND NOTIFY HIM IF THE SKIN STARTED TO GET WORSE. AT 30MG OF PREDNISONE, THE SKIN STARTED TO REDDEN AND WEEP AGAIN. HE THEN SAID, I NEEDED TO SEE A DERMATOLOGIST. DATES OF USE: (B)(6) 1990 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPT PASTE EZR HOLLISTER INCORPORATED CONSUMER PROGRAMS TEAMS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other ILEAOSTOMY WAFER| CONVETEC