BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16862763 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00029
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    November 24, 2021
    Report Date
    December 30, 2021
    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

    USED DEVICE FOR TWO WEEKS STARTED TO HAVE EYE TWITCH/ LAXY EYE AND BELIEVED IT TO BE ATTRIBUTED TO THE USE OF THE FWS. USER DID NOT RETURN CALLS THROUGH JANUARY 14TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533854 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other