BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 20189434 · Received September 11, 2024

    Report

    Report Number
    3012316249-2024-00016
    Event Type
    Injury
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
    Product Code
    GYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AFFECTED PRODUCTS: B00NCRE4GO - TENS 7000 DIGITAL TENS UNIT WITH ACCESSORIES - TENS UNIT MUSCLE STIMULATOR FOR BACK PAIN RELIEF, SHOULDER PAIN RELIEF, NECK PAIN, SCIATICA PAIN RELIEF, NERVE PAIN RELIEF. ASIN VARIATIONS: NA. CUSTOMER FEEDBACK: [09/10/2024: "DOES NOT STIMULATE. SHOCKS. CAUSED ME TO GO INTO CARDIAC ARREST."].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510949 COMPASS HEALTH BRANDS TENS 7000 DIGITAL GYB SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. DT7202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization