BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESGIN 50

    MDR report key: 12026 · Received March 11, 1994

    Report

    Report Number
    MW1001072
    Event Type
    Injury
    Date Received
    March 11, 1994
    Date of Event
    May 1, 1989
    Report Date
    February 17, 1994
    Manufacturer
    GENERAL ELECTRIC CO.
    Product Code
    FTD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES THAT WITHOUT HER KNOWLEDGE OR PERMISSION HER EMPLOYER PLACED A BLUE SPECTRUM LIGHT FOR THE MFR. THE LIGHTING WAS NOTICEABLY BRIGHTER THAN THE PREVIOUS FLUORESCENT LIGHTING. OVER A PERIOD OF TIME RPTR'S EYES BECAME INCREASINGLY INTOLERANT OF BEING EXPOSED TO LIGHT (FLUORESCENT). THE NUMBER OF TUBES DID NOT HELP, BUT THE "BLUE LIGHT" WAS EXCESSIVELY BRIGHT. RPTR WAS DENIED THE OPTION OF DIMMING THE LIGHTS TO COMFORT BECAUSE IT WAS FELT THAT IT WOULD AFFECT THE STUDY. AS A RESULT, RPTR'S EYES ARE SO SENSITIVE TO BRIGHT LIGHT THAT EXPOSURE (LESS THAN AN HR) CAUSED BILATERAL EYE STRAIN, PAIN AND ACUTE RIGHT EYE PAIN, PLUS PHOTOPHOBIA. THE STUDY HOPED TO PROVE THAT BLUE LIGHTS INCREASE CREATIVITY AND DECREASE USE OF PAIN MEDICATION IN PTS. ALSO, THE BLUE LIGHTS CAUSED HER TO HAVE ACUTE INSOMNIA. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESGIN 50 FLUORESCENT LIGHTING FTD GENERAL ELECTRIC CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Not Applicable