BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOX BRAIN HEALTH SYSTEM

    MDR report key: 11912713 · Received May 28, 2021

    Report

    Report Number
    MW5101634
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    EVOKE NEUROSCIENCE, INC.
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY FAMILY MEMBER HAD AN IMAGING TEST DONE THAT FALSELY CLAIMED TO BE AN EARLY DETECTION FOR EARLY INTERVENTION OF ALZHEIMER'S DISEASE. THE "EVOX BRAIN HEALTH SYSTEM" CLAIMS TO IDENTIFY THE UNDERLYING CAUSES OF COGNITIVE IMPAIRMENT, WHILE THERE IS STILL TIME TO TREAT. (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801360 EVOX BRAIN HEALTH SYSTEM FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH GWQ EVOKE NEUROSCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention