BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX BORDER POST-OP AG

    MDR report key: 9581174 · Received January 10, 2020

    Report

    Report Number
    MW5092183
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEPILEX BORDER POST-OP AG DRESSING NOTED TO BE DISCOLORED (TAN / BROWNISH) AROUND THE DRESSING'S EDGE. DRESSING REMOVED FROM SURGICAL FIELD AND REPLACED WITH "LIKE" DRESSING WITHOUT ANY IDENTIFIED DRESSING ISSUES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36791 MEPILEX BORDER POST-OP AG DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE US LLC 498450 19319609

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR