BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5154126 · Received October 15, 2015

    Report

    Report Number
    9618003-2015-30585
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    August 5, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC DOM. REPUBLIC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    END USER REPORTS RED BROKEN SKIN UNDER THE ENTIRE WAFER. THIS INCLUDES UNDER THE MASS AND THE ADHESIVE TAPE BORDER. HE REPORTS THAT IT WAS RED; BLISTERED; BLEEDING AND PAINFUL. HE WENT TO THE EMERGENCY ROOM LAST WEEK. THEY INSTRUCTED HIM TO STOP USING A DURAHESIVE WAFER. HE WAS GIVEN A POWDER; AN UNKNOWN SKIN PROTECTOR AND AN APPLIANCE. PRODUCT USE AND SKIN CARE INSTRUCTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683170 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC DOM. REPUBLIC 413162 3H01247

    Patients

    Seq Age Sex Outcome Treatment
    1