BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA INVISI STD TAN BSF 45MM

    MDR report key: 5153713 · Received October 15, 2015

    Report

    Report Number
    9618003-2015-30562
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    July 22, 2013
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    CUSTOMER REPORTS DEVELOPING REDNESS AND IRRITATION WHERE THE TAIL CLOSURE RUBS ON HER SKIN. SHE USES CLOROX BLEACH TO CLEANSE THE TAIL CLOSURE. SHE RECENTLY STARTED USING A CLOSED END POUCH AND SINCE USING IT THE REDNESS AND IRRITATION HAS ALMOST COMPLETELY RESOLVED. PRODUCT USE AND SKIN CARE INSTRUCTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684625 NATURA INVISI STD TAN BSF 45MM POUCH, COLOSTOMY EZQ CONVATEC DOM. REPUBLIC 413334

    Patients

    Seq Age Sex Outcome Treatment
    1