BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVEMEDICAL

    MDR report key: 9753572 · Received February 26, 2020

    Report

    Report Number
    9753572
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 29, 2020
    Manufacturer
    MEDICAL DEPOT, INC.
    Product Code
    GXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES SHE WAS PRESCRIBED A TENS UNIT FOR HER BROKEN BACK THAT CAUSED SEVERE SCIATIC NERVE DAMAGE. SHE REPORTS SHE WAS LAYING DOWN WITH THE MACHINE PATCHES ON HER OUTER RIGHT THIGH WHEN A LIVE WIRE CAME OUT OF A PATCH. WHERE THE LIVE WIRE TOUCHED HER OUTER RIGHT BUTTOCK, IT LEFT A BURN. SHE REPORTS THE BATTERY PART DOES NOT WORK PROPERLY. THE VIBRATION AND PULSE WORKS SOME OF THE TIME AS DIALED THEN GOES VERY LOW OR DOES NOT WORK AT ALL. OUR MEDICAL SUPPLY OFFICE BELIEVES THE PATIENT WAS NOT USING THIS APPROPRIATELY AS THE LEAD WIRES WERE LOOSE TO THE ELECTRODES. WE BELIEVE SHE PULLED THE ELECTRODES OFF WITH THE LEAD WIRES CAUSING THE WIRE TO BE EXPOSED INSTEAD OF PEELING THEM OFF. OUR EMPLOYEE SHOWED THE PATIENT THAT THE LEAD WIRES AND THE ELECTRODES NEEDED TO BE INTAKE BEFORE USING (IT APPEARED THEY WERE PULLED ON AND LOOSE WHICH COULD HAVE CAUSED THE WIRE TO BE EXPOSED). SHE ALSO REVIEWED THE INSTRUCTION BOOKLET WITH THE PATIENT AND ASKED HER TO F/U WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216297 DRIVEMEDICAL ELECTRODE, CUTANEOUS GXY MEDICAL DEPOT, INC. AGF-3X

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Other