BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5138740 · Received October 8, 2015

    Report

    Report Number
    1049092-2015-30671
    Event Type
    Injury
    Date Received
    October 8, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). EVALUATION CONCLUSIONS ARE REFLECTED IN THE CODES.

    Description of Event or Problem · 1

    CUSTOMER REPORTS FOR PAST 8 MONTHS NOTED MASS DIFFICULT TO REMOVE AND SKIN IS NOW RAW AND IRRITATED. DISCUSSED SKIN CARE. USES SOAP AND WATER AND CURRENTLY APPLYING NEOSPORIN OVER THE COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666882 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC, INC. 413160 4A03476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention