BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO

    MDR report key: 6743572 · Received July 24, 2017

    Report

    Report Number
    MW5071233
    Event Type
    Injury
    Date Received
    July 24, 2017
    Report Date
    July 24, 2017
    Manufacturer
    NEURAL ANALYTICS
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEURAL ANALYTICS IS DEVELOPING AND TESTING AUTOMATED BRAIN SCANNING. I UNDERWENT BRAIN SCANS TO HELP THEM DEVELOP THE PRODUCT. THE SCAN LASTED A TREMENDOUSLY LONG TIME. DURING THE PROCEDURE I FELT SENSATIONS IN MY BRAIN AND SAID SO BUT THE EMPLOYEES SEEMED INDIFFERENT. IMMEDIATELY AFTER THE SCANNING I HAD A SIGNIFICANT HEADACHE AND DIZZY. I COULD NOT THINK CLEARLY. I COULD NOT SEE CLEARLY. I TOOK ADVIL TO TRY TO NUMB THE SENSATION AND HAVE BEEN TAKING IT ALMOST CONTINUOUSLY SINCE THAT TIME. I AM AFRAID TO REPORT TO THE COMPANY. I AM AFRAID THEY MAY HAVE SCANNED ME TOO LONG OR WITH TOO MUCH POWER. I AM AFRAID THAT THE AUTOMATED SYSTEM MAY HAVE CAUSED SOME DAMAGE TO MY BRAIN. I AM AFRAID THAT I MAY HAVE PERMANENT DISABILITY AS A RESULT OF TRYING TO HELP THE COMPANY. THESE ARE A BUNCH OF YOUNG GIRLS SEEMING TO BE HELL BENT ON MAKING SOMETHING FOR FINANCIAL GAIN AND POTENTIALLY INJURING OR KILLING VOLUNTEERS IN THE PROCESS. THIS IS SORT OF A "FRANKENSTEIN" COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517356 APOLLO TRANSSCRANIAL DOPPLER ULTRASOUND IYN NEURAL ANALYTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S