BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYROSTIM

    MDR report key: 5650750 · Received March 29, 2016

    Report

    Report Number
    MW5062224
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    November 4, 2014
    Report Date
    March 29, 2016
    Manufacturer
    ULTRA THERA TECHNOLOGIES, INC
    Product Code
    MHZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE AT (B)(6), WAS INSIDE THE GYROSTIM MACHINE FOR TREATMENT, WHEN THE MACHINE CONTINUOUSLY WENT IN ONE DIRECTION, WHICH WAS NOT PART OF PLAN. WHEN THE DOCTOR ON HAND TOLD THE MACHINE TO STOP, THE MACHINE CRASHED INSTEAD OF GLIDING TO A STOP. NEUROLOGICAL PROBLEMS GOT WORSE AS DID PROBLEMS WITH FATIGUE AND STAMINA. WAS LAID UP FOR A FEW WEEKS. WAS ALSO LATER TOLD AFTER DOCTOR SPOKE WITH INVENTOR THAT THIS COULD HAVE BEEN SUPPOSEDLY PREVENTED WITH A SHORT PROTOCOL CHECK. I DON'T WANT THIS HAPPENING TO MORE PEOPLE. SUPPOSEDLY, A BUTTON HAD BEEN HALF PRESSED WHICH CAUSED MACHINE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189768 GYROSTIM MHZ ULTRA THERA TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability