BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX BORDER POST-OP AG DRESSING

    MDR report key: 9853361 · Received March 18, 2020

    Report

    Report Number
    MW5093841
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 17, 2020
    Manufacturer
    MOLNLYCKE HEALTH CARE, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THREE MEPILEX BORDER POST-OP AG DRESSING WERE OPENED AND NOTED TO BE A TANNISH / BROWNISH COLOR AROUND THE EDGES. TWO WERE FROM ONE LOT NUMBER AND ONE FROM ANOTHER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309911 MEPILEX BORDER POST-OP AG DRESSING DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE, INC. 498600 19350324
    309912 MEPILEX BORDER POST-OP AG DRESSING DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE, INC. 498600 19350324
    309913 MEPILEX BORDER POST-OP AG DRESSING DRESSING, WOUND, DRUG FRO MOLNLYCKE HEALTH CARE, INC. 498600 19480491

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR