BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEPILEX BORDER POST OP

    MDR report key: 21221241 · Received January 22, 2025

    Report

    Report Number
    MW5165165
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    November 26, 2024
    Report Date
    January 20, 2025
    Manufacturer
    MOLNLYCKE MANUFACTURING US, LLC/MOLNLYCKE HEALTH CARE US LLC.
    Product Code
    NAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ORTHOPEDIC SURGEON USED MEPILEX BORDER POST-OP DRESSING TO TOTAL KNEE REPLACEMENT INCISION SITE. HE FEELS CHANGES MADE TO THIS PRODUCT BY MANUFACTURER LATE 2024 RESULTED IN PATIENT DEVELOPING A BLISTERING, SHEARING SKIN INJURY REQUIRING HOSPITALIZATION FOR SURGICAL INCISION AND DRAINAGE, WOUND VAC PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607036 MEPILEX BORDER POST OP DRESSING, WOUND, HYDROPHILIC NAC MOLNLYCKE MANUFACTURING US, LLC/MOLNLYCKE HEALTH CARE US LLC. 496455 24204626

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization