BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 20211148 · Received September 13, 2024

    Report

    Report Number
    3012316249-2024-00017
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    March 20, 2024
    Report Date
    September 13, 2024
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    HE IS A PRISONER CURRENTLY INCARCERATED IN THE (B)(6) MEDICAL AND CLASSIFICATION CENTER IN (B)(6) . ON (B)(6) 2024 HE WAS TREATED BY A TENS DEVICE ON HIS LOWER BACK, 4 ELECTRODES. THIS INCIDENT OCCURRED ON THE 4TH TREATMENT AS THE FIRST 3 WENT NORMAL. SEVERAL HOURS LATER HE WAS WORKING AND HIS LOWER BACK BEGAN TO HURT SEVERELY AND FOUND HIS LOWER BACK WAS WET. HE WENT TO HEALTH SERVICES AND WAS SEEN BY A NURSE AND WAS TOLD HE HAS 2ND DEGREE BURNS IN SEVERAL LOCATIONS. BEGINNING ON (B)(6) 2024 THROUGHOUT (B)(6) 2024, PICTURES WERE TAKEN OF ONGOING INJURIES. SINCE THIS OCCURRED, HE HAS HAD TO RECEIVE DAILY DRESSING CHANGES OF THE BURNS. STATES HE IS STILL IN PAIN AND SUFFERS PTSD SURROUNDING THE EVENT. STATES HE HAS WRITTEN TO SEVERAL LAWYERS FOR ASSISTANCE AS HE BELIEVES THE MEDICAL DEPARTMENT AND THE MANUFACTURER OF THE DEVICE SHOULD BE HELD RESPONSIBLE FOR HIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157883 COMPASS HEALTH BRANDS PERFORMA COMBIN8 DUO GYB SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. PH8200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other