BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISCHER WALLACE STIMULATOR

    MDR report key: 6002826 · Received October 4, 2016

    Report

    Report Number
    MW5065212
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    August 6, 2016
    Report Date
    October 4, 2016
    Manufacturer
    FISCHER WALLACE LABORATORIES
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING FDA APPROVED FISCHER WALLACE STIMULATOR FOR INSOMNIA AFER TWO HOURS I GOT TREMOR, SEVERE MUSCLE SPASMS, AND DIZZINESS, WENT TO URGENT CARE TWO TIMES THEN TO ER AND NEUROLOGIST AND SHE TOLD ME THIS DEVICE TRIGGER DISEASE MS, WHICH I NEVER KNEW BEFORE I HAD IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649841 FISCHER WALLACE STIMULATOR FISCHER WALLACE STIMULATOR GZJ FISCHER WALLACE LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention| S FISH OIL