BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE REBUILDER

    MDR report key: 1291403 · Received January 16, 2009

    Report

    Report Number
    MW5009620
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 16, 2009
    Manufacturer
    REBUILDER MEDICAL TECHNOLOGIES, INC.
    Product Code
    GZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATES THAT IF YOU TOUCH THE KNOB TOO HARD, IT SLIDES AND YOU GET A SHOCK THAT FEELS LIKE YOU ARE BEING SHOCKED WITH A TASER DEVICE. SHE SAYS THIS HAPPENED TO HER AND SHE FELT PARALYZED. RPTR SAYS THE DIGITAL TENS UNITS WORK BETTER, THAT THIS ONE IS DANGEROUS. RPTR NOTIFIED THE MFR AND THEY LAUGHED SAYING THE DEVICE IS FDA APPROVED. MFR REFUSED TO EVALUATE THE DEVICE. RPTR FEELS IT IS A POOR DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE REBUILDER TENS UNIT GZJ REBUILDER MEDICAL TECHNOLOGIES, INC. 2407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention