BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5145928 · Received October 13, 2015

    Report

    Report Number
    1049092-2015-30421
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    January 31, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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

    OPEN AREA AT 5OCLOCK TO PERISTOMAL SKIN APPROX 13MM. WOUND IS BLEEDING SMALL AMOUNT AND SEEMS TO BE SUPERFICIAL. RECOMMENDED COLD COMPRESS; HAND LOTION; ICE; SH POWDER; SKIN PREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676669 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC, INC. 413161 3E01419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CALCIUM