BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYGNET EEG

    MDR report key: 5630032 · Received May 1, 2016

    Report

    Report Number
    MW5062066
    Event Type
    Injury
    Date Received
    May 1, 2016
    Manufacturer
    BEE SYSTEMS
    Product Code
    HCC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD 300 TOTAL SESSIONS OF NEUROFEEDBACK, MORE THAN ANYONE FOR MAJOR DEPRESSION, ADHD 100. OF THEM "WERE OTHER PLAN" BY EEG INFO CYGNET JUST TO GET LITTLE BUZZ, AS ANY ENERGY DRINK PROMISED. THIS JUNK CURES. SPENT TOTAL (B)(6) FOR TREATMENT. PRACTITIONER WAS LISTED AS MD, BUT HE WAS A SCAMMER. THEY SUGGESTED TO ME AND ALL HIS PATIENTS TO BUY THE DEVICE WITHOUT PRESCRIPTION OR SAFETY HAZARD. LEAD TO SERIOUS ADVERSE EFFECT, HARM TO COHERENCE, TICKS, CAR ACCIDENT, DYSFUNCTION, SEVERE AGITATION, DELETION, IMPAIRMENT OF SHORT TERM MEMORY, AND SERIOUS LEARNING PROBLEM. I WAS NOT ABLE TO FOLLOW INSTRUCTION AND COMPANY COULDN'T FIX IT. IT'S LONG TERM AND DISABLES ME. I CAN'T DRIVE SAME AREAS, IT RUINED MY LIFE. I HOPE OWNER GOES TO JAIL. I'M OPEN TO MEDIA. BRAIN TESTING SPEAKS FOR ITSELF. I'M OPEN TO MEDWATCH. EXPERTS, YOU CAN EASILY HURT YOURSELF LONG TERM NOT ESTABLISHED". SCAM IS GO MORE YOU BE CURED". RECENTLY DUE TO WORSENING AND ADD'L ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278391 CYGNET EEG CYGNET EEG HCC BEE SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR