BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL TENS UNIT, 2/4 ELECTRODES

    MDR report key: 4213289 · Received October 6, 2014

    Report

    Report Number
    1060680-2014-00039
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BIO PRETCH, INC.
    Product Code
    GZJ
    PMA / PMN Number
    K022841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED THAT ONCE SHE PLUGS UNIT IN AND TURNS THE SYSTEM ON IT SHOCKS HER. PATIENT STATED THAT IT HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625117 DIGITAL TENS UNIT, 2/4 ELECTRODES STIMULATOR, NERVE TRANSCUTANEOUS, F GZJ BIO PRETCH, INC. 1197904

    Patients

    Seq Age Sex Outcome Treatment
    1