BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA WFR MLD CVX 22/45MM

    MDR report key: 5153732 · Received October 15, 2015

    Report

    Report Number
    1049092-2015-30563
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SATED THAT WHEN HE CHANGED HIS WAFER LAST WEEK AND THIS WEEK THE STOMA BLED JUST A LITTLE PINK FLUID AND THEN STOPPED. BLEEDING MIGHT COME FROM CLEANSING AROUND THE STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685000 NATURA WFR MLD CVX 22/45MM PROTECTOR, OSTOMY EXE CONVATEC INC. 404593

    Patients

    Seq Age Sex Outcome Treatment
    1