BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX DRESSING BORDER POST-OP AG

    MDR report key: 9610858 · Received January 17, 2020

    Report

    Report Number
    MW5092365
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    January 15, 2020
    Report Date
    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 DISCOLORED, A BROWNISH COLOR, WHEN THE STERILE PACKAGING WAS OPENED X 2 DRESSINGS WITH THE SAME LOT NUMBER. FDA SAFETY REPORT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63109 MEPILEX DRESSING BORDER POST-OP AG DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE US LLC 498600 19319608
    63110 MEPILEX DRESSING BORDER POST-OP AG DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE US LLC 498600 19319608

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR