BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX BORDER POST-OP AG/ MEPILEX DRESSING

    MDR report key: 9610708 · Received January 17, 2020

    Report

    Report Number
    MW5092356
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    January 15, 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 WAS DISCOVERED TO BE DISCOVERED (BROWNISH IN COLOR). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62553 MEPILEX BORDER POST-OP AG/ MEPILEX DRESSING DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE US, LLC 498600 19187779

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR