BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16863074 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00044
    Event Type
    Injury
    Date Received
    May 3, 2023
    Report Date
    January 8, 2023
    Manufacturer
    FISHER WALLACE LABS
    Product Code
    QJQ
    PMA / PMN Number
    K903654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PEOPLE THAT HAVE METAL IN THEIR HEADS SHOULD NOT USE THIS PRODUCT. I SPENT (B)(6) ON IT AND WAS HOPING FOR SOME GOOD RESULTS AND REALIZED I WAS SEEING THE METAL COILS IN MY HEAD. FELT LIKE ELECTROCUTING BEHIND MY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715136 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other