BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE STIMULATOR 2 MA

    MDR report key: 5148147 · Received October 7, 2015

    Report

    Report Number
    MW5056948
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 7, 2015
    Manufacturer
    FISHER WALLACE LABORATORIES
    Product Code
    JXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT USED A BRAIN STIMULATOR TO STIMULATE NEUROCHEMICAL PRODUCTION. EXPERIENCED HEADACHES AND HAD A NIGHTMARES. PT USED A FISHER WALLACE STIMULATOR AT LEAST ONCE BETWEEN (B)(6) 2015 ON A SETTING BETWEEN 1 AND 4 MA FOR ANYWHERE FROM 1 TO 20 MINUTES. FREQUENCY: TWICE DAILY; ROUTE: TRANSCRANIAL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664268 FISHER WALLACE STIMULATOR 2 MA CRANIAL STIMULATOR JXK FISHER WALLACE LABORATORIES FW-100 PO-129

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other