BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAHESIVE. WFR W/NATURA FLG

    MDR report key: 5155817 · Received October 16, 2015

    Report

    Report Number
    1049092-2015-30649
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    October 21, 2014
    Report Date
    February 27, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (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

    IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE WAFER MASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685687 DURAHESIVE. WFR W/NATURA FLG PROTECTOR, OSTOMY EXE CONVATEC INC. 413161 4J00416

    Patients

    Seq Age Sex Outcome Treatment
    1