BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIAL NEUROSTIMULATOR

    MDR report key: 16861999 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00027
    Event Type
    Injury
    Date Received
    May 3, 2023
    Report Date
    December 12, 2022
    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 THE DEVICE FOR 3 DAYS. THIS MORNING I WOKE UP WITH RINGING IN MY EARS. I RESEARCHED THE ISSUE. UNFORTUNATELY, I HAVE TINNITUS, A SIDE EFFECT CAUSED BY USING THIS DEVICE. PLEASE ADVISE HOW TO RETURN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533813 FISHER WALLACE CRANIAL NEUROSTIMULATOR CRANIAL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other