BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEPILEX BORDER POST-OP AG SILICONE DRESSING

    MDR report key: 9489425 · Received December 17, 2019

    Report

    Report Number
    MW5091714
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 13, 2019
    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

    MULTIPLE MEPILEX BORDER POST- 0P AG NOTED WITH BROWN DISCOLORATION, IN BOTH SIZES (4X10 AND 4X12), REF. #¿S 498450, 498600. LOT #¿S: 19227859 & 19231108. EXP. DATES: 02/28/2022, 04/28/2022 & 05/28/2022. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277458 MEPILEX BORDER POST-OP AG SILICONE DRESSING DRESSING, WOUND, HYDROPHILIC NAC MOLNLYCKE HEALTH CARE, US LLC 498450 19133107
    1277459 MEPILEX BORDER POST-OP AG SILICONE DRESSING DRESSING, WOUND, HYDROPHILIC NAC MOLNLYCKE HEALTH CARE, US LLC 498600 19227859
    1277460 MEPILEX BORDER POST-OP AG SILICONE DRESSING DRESSING, WOUND, HYDROPHILIC NAC MOLNLYCKE HEALTH CARE, US LLC 19231108

    Patients

    Seq Age Sex Outcome Treatment
    1