BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX BORDER POST-OP AG

    MDR report key: 9805357 · Received March 6, 2020

    Report

    Report Number
    MW5093619
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 5, 2020
    Manufacturer
    MOLNLYCKE HEALTH CARE US LLC
    Product Code
    NAC
    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 (BROWN) AROUND THE DRESSING'S EDGES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266726 MEPILEX BORDER POST-OP AG DRESSING, WOUND, HYDROPHILIC NAC MOLNLYCKE HEALTH CARE US LLC 498450 19319609

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR