BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXELGAARD ELECTRODE PADS

    MDR report key: 19827249 · Received July 24, 2024

    Report

    Report Number
    MW5157546
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 22, 2024
    Manufacturer
    AXELGAARD MFG. CO., LTD.
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE LAST WEEK, HAVE NOTED 2 OCCURRENCES WHERE PATIENTS WERE SUPERFICIALLY BURNED BY ELECTRODE PADS THAT WERE USED WITH 2 DIFFERENT XCITE2 FUNCTIONAL ELECTRICAL STIMULATION (E-STIM) DEVICES. AXELGAARD NEUROSTIMULATION ELECTRODE PADS FROM LOT # 205342. REF REPORT: MW5157545.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913824 AXELGAARD ELECTRODE PADS ELECTRODE, CUTANEOUS GXY AXELGAARD MFG. CO., LTD. 205342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other