BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOMAHESIVE WAFER WITH SUR-FIT FLANGE

    MDR report key: 597722 · Received April 30, 2005

    Report

    Report Number
    1049092-2005-00022
    Event Type
    Other
    Date Received
    April 30, 2005
    Date of Event
    April 1, 1997
    Report Date
    April 29, 2005
    Manufacturer
    CONVATEC
    Product Code
    EXB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF PERISTOMAL ITCHING WITH RED RASH. SWITCHED FROM DURAHESIVE TO STOMAHESIVE WAFER APRIL/MAY 1996. PERISTOMAL SKIN BECAME VERY FRAGILE AND RAW. IN 3/1997, DISCOURAGE WITH PROGRESS, PHYSICIANS DISCONTINUED ALL OINTMENTS AND CUSTOMER WAS ONLY USING STOMAHESIVE WAFER. IN 3/1997 CUSTOMER WAS SEEN BY ANOTHER DERMATOLOGIST. IRRITATION AND ITCHING OF PERISTOMAL SKIN WORSENED. PHYSICIAN PRESCRIBED 20MG PREDNISONE WITH WAFER CHANGES EVERY OTHER DAY IN 4/1997. PERISTOMAL SKIN SHOWED SOME IMPROVEMENT WITH MILD EPISODES OF REDNESS AND ITCHINESS. ON 7/1997 SKIN TESTS WERE FOUND TO BE POSITIVE FOE STOMAHESIVE AND DURAHESIVE WAFERS. ADVISED CUSTOMER TO DISCONTINUE USE OF PRODUCTS DUE TO ALLERGIC REACTION. IN 1998 PT HAD SURGERY FOR A CONTINENT UROSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOMAHESIVE WAFER WITH SUR-FIT FLANGE OSTOMY APPLIANCE EXB CONVATEC NA 97019976

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other BACTROBAN, 20MG PREDNISONE, PSORCON CREAM.| LOTRISOME CREAM, DIPROLENE CREAM, COLBELTAZOL,