BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM PCH DRNWFINVISITAN60/70MM

    MDR report key: 5154007 · Received October 15, 2015

    Report

    Report Number
    9618003-2015-30575
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    END USER REPORTS THAT FOR LAST 6 MONTHS THAT SHE BEGAN USING POUCHES HAS HAD DIFFICULTY REMOVING POUCH FROM SKIN. STATES USES AN ADHESIVE REMOVER WIPES AND THEN WASHES WITH NON MOISTURIZING SOAP AND WATER THEN RINSES AND DRIES SKIN AND APPLIED SAFE AND SIMPLE (B)(6) WIPES AND ALLOWS TO DRY THEN WAFER. STATES HAS ALSO TRIED ANOTHER ADHESIVE REMOVER AND PROTECTIVE (B)(6) WIPES. WILL CUT TAPE COLLAR OFF AND TRIAL SAMPLE. CHANGING APPLIANCE EVERY 12 TO 24 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683863 ESTEEM PCH DRNWFINVISITAN60/70MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC 416719 4A00640

    Patients

    Seq Age Sex Outcome Treatment
    1