BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULIGHT

    MDR report key: 238510 · Received September 1, 1999

    Report

    Report Number
    MW1017083
    Event Type
    Malfunction
    Date Received
    September 1, 1999
    Date of Event
    August 1, 1999
    Report Date
    September 1, 1999
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR HAS HAD POOR RESULTS WITH THESE SYSTEMS. WHEN SHE CONSULTED THE MFR, SHE WAS ADVISED TO INCREASE THE HEAT SETTING AND THE NUMBER OF PASSES PER APPLICATION, WELL BEYOND THE FDA APPROVED LIMIT. THE RECOMMENDATION WAS ALSO CLEARLY ABOVE THE RECOMMENDED SETTINGS IN THE OPERATOR'S MANUAL. THE RPTR IS CONCERNED THAT OTHERS MAY TAKE THIS ADVICE AND IT WILL RESULT IN AN INJURY. SHE WAS ALSO CONCERNED THAT THE CO WOULD EVEN MAKE SUCH A RECOMMENDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT LASER VARICOSITY REMOVAL SYSTEM GEX ESC MEDICAL SYSTEMS, INC. * *
    2 EPILIGHT LASER HAIR REMOVAL SYSTEM GEX ESC MEDICAL SYSTEMS, INC. * *
    3 SILK LIGHT LASER TATOO REMOVAL SYSTEM GEX ESC MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA