BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CES

    MDR report key: 1393846 · Received May 25, 2009

    Report

    Report Number
    MW5011219
    Event Type
    Injury
    Date Received
    May 25, 2009
    Date of Event
    May 10, 2009
    Report Date
    May 25, 2009
    Manufacturer
    FISHER WALLACE LABORATORIES LLC
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USE OF CES BY COMPANY CAUSED LONG LASTING HEADACHE, DEEPENING OF MINOR DEPRESSION TO THE POINT OF DESPAIR, UNDUE SLEEPINESS WITH DESIRE TO NOD OFF WHILE DRIVING. THE DEVICE WAS USED AS DIRECTED FOR 3 DAYS ONLY. SLUGGISH DURING THE DAY HAS PERSISTED MUCH TO MY DISMAY. THESE SYMPTOMS OCCURRED ABRUPTLY AND HAVE PERSISTED. FREQUENCY: QD. ROUTE: OTHER. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE : TO TREAT DEPRESSION/ANXIETY/PAIN. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER WALLACE CES CES, 20 MINUTE TREATMENT QD JXK FISHER WALLACE LABORATORIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other