BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE STIMULATOR

    MDR report key: 5147879 · Received October 7, 2015

    Report

    Report Number
    MW5056926
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    June 11, 2015
    Report Date
    October 7, 2015
    Manufacturer
    FISHER WALLACE LABORATORIES
    Product Code
    JXK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, IN THE MORNING, USED FISHER WALLACE CRANIAL ELECTRO STIMULATOR FOR FIRST (AND ONLY) TIME. DUE TO THE PRODUCT DEFUSE (LACK OF SAFELY FEATURES), I ACCIDENTALLY KICKED THE INTENSITY LEVEL SLIDE UP. DIDN'T REALIZE IT TILL NEAR END OF TREATMENT (AT 20MIN). I WAS AT HIGH LEVEL INSTEAD OF LOW LEVEL. SUFFERED PROMPT ADVERSE EFFECTS OF HYPER EXCITEMENT, THEN LIGHTHEADEDNESS, RINGING IN EARS, INABILITY TO CONCENTRATE (LOSS OF SHORT-TERM MEMORY), CRAWLING SENSATION IN MY TEMPLES. BECAME VERY ANXIOUS AND DEPRESSION AS A RESULT (WITH PRE-EXISTING CONDITION - EXACERBATED). HAVE NOT FULLY RECOVERED FROM THE ADVERSE SYMPTOM. PRINCIPALLY INCREASED DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664116 FISHER WALLACE STIMULATOR FISHER WALLACE STIMULATOR JXK FISHER WALLACE LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| S