BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE STIMULATOR

    MDR report key: 10413262 · Received August 14, 2020

    Report

    Report Number
    MW5096089
    Event Type
    Injury
    Date Received
    August 14, 2020
    Report Date
    August 13, 2020
    Manufacturer
    FISHER-WALLACE LABORATORIES, INC.
    Product Code
    JXK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED AS DIRECTED AT POWER SETTING #2 FOR 20 MINUTES, ONCE PER DAY, ON 3 DIFFERENT DAYS. EACH TIME I WAS LEFT WITH A PERSISTENT HEADACHE, VERY SHAKY HANDS, A FEELING OF WEAKNESS AND FATIGUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870547 FISHER WALLACE STIMULATOR CRANIAL ELECTROTHERAPY STIMULATOR TO TREAT DEPRESSION JXK FISHER-WALLACE LABORATORIES, INC. FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other