BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAIN STATE CONDITION

    MDR report key: 1132904 · Received August 25, 2008

    Report

    Report Number
    MW5008067
    Event Type
    Other
    Date Received
    August 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BRAIN STATE CONDITION
    Product Code
    HCC
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT SHE IS UNABLE TO SLEEP AND FEELS LIKE SHE IS IN A COMA AFTER USING THE BRAIN STATE CONDITION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAIN STATE CONDITION BRAIN STATE CONDITION HCC BRAIN STATE CONDITION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR