BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA PCH URO ACU STD CLR 45MM

    MDR report key: 5135518 · Received October 8, 2015

    Report

    Report Number
    9618003-2015-30528
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    May 9, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 POUCH LONG AND UPPER PORTION OF THE BACK OF THE POUCH RUBS ON HER SKIN. AREA RED. REPORTS SHE PUTS REGULAR POWDER ON THE SKIN AND PLACES TOWEL BETWEEN POUCH AND SKIN. PRODUCT USE AND SKIN CARE INSTRUCTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665676 NATURA PCH URO ACU STD CLR 45MM BAG, URINARY, ILEOSTOMY EXH CONVATEC DOM. REPUBLIC 401544 3M00380

    Patients

    Seq Age Sex Outcome Treatment
    1