BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16862016 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00039
    Event Type
    Injury
    Date Received
    May 3, 2023
    Report Date
    December 8, 2022
    Manufacturer
    FISHER WALLACE LABS
    Product Code
    QJQ
    PMA / PMN Number
    K903654
    Removal / Correction Number
    RES 91982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    HELLO. I TRIED THE UNIT AND I THINK IT IS FAULTY. THE GREEN LIGHT ALWAYS BLINKS AND THE ON OFF DIAL DOESN'T TURN IT OFF EVEN WHEN CLICKED IN THE OFF POSITION. WHEN I MANUALLY WENT TO REMOVE THE BATTERY THE TERMINAL POSTS WHERE EXTREMELY HOT AND BURNED MY FINGER. CAN I EXCHANGE THIS FOR A NEW UNIT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811250 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other