BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC-STOMAHESIVE WAFER W/FLEX

    MDR report key: 3378303 · Received September 26, 2013

    Report

    Report Number
    1049092-2013-00049
    Event Type
    Injury
    Date Received
    September 26, 2013
    Date of Event
    August 21, 2013
    Report Date
    August 28, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    EXB
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A SERIOUS INJURY. ACCORDING TO THE REPORTER, HE REMOVES THE APPLIANCE USING ALLKARE ADHESIVE REMOVER, HE REMOVES THE APPLIANCE USING ALLKARE ADHESIVE REMOVER, THEN WASHES WITH LYE SOAP WITH SCRUBBER, RINSES AND DRIES, AND THEN APPLIES WAFER. THE END USER RECENTLY SAW A DERMATOLOGIST WHO REFERRED HIM TO A WOUND CARE NURSE. THE END USER WILL CALL MD FOR ANTIFUNGAL. FROM A CLINICAL PERSPECTIVE, A CASUAL RELATIONSHIP BETWEEN THE SUR-FIT NATURA 2 PC DURAHESIVE FLEXIBLE WAFER WITH FLEXIBLE COLLAR AND THIS EVENT IS DEEMED POSSIBLE BECAUSE THE PRODUCT IN USE IS TEMPORALLY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED. NO ADD'L EVENT/PT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    END USER REPORTS APPROXIMATELY ONE WEEK AGO DEVELOPING FLUID FILLED BLISTERS UNDER TAPE COLLAR IN VARIOUS LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487362 SUR-FIT NATURA 2 PC-STOMAHESIVE WAFER W/FLEX OSTOMY POUCH AND ACCESSOREIS EXB CONVATEC INC 125272 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention