BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER ET

    MDR report key: 830621 · Received March 13, 2007

    Report

    Report Number
    2914019-2005-00097
    Event Type
    Other
    Date Received
    March 13, 2007
    Date of Event
    August 5, 2005
    Report Date
    March 13, 2007
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHTSHEER DEVICE WAS EVALUATED BY LUMENIS SERVICE. PER THE SERVICE DEPOT, NO PROBLEMS WERE FOUND WITH THE SYSTEM'S ENERGY OUTPUT OR COOLING PERFORMANCE. ROOT CAUSE: TWO PTS WERE TREATED AGGRESSIVELY FOR SKIN TYPE, PER THE LUMENIS CLINICAL EDUCATOR. OTHER PTS WERE TREATED AT THE UPPER END OF THE PHYSICIAN RECOMMENDED PRESETS. NO FURTHER CONCLUSION CAN BE DRAWN. THE CUSTOMER HAD PREVIOUS CLINICAL TRAININGS BY LUMENIS IN 2004. THE CUSTOMER OBTAINED ADD'L TRAINING FROM LUMENIS IN 2005.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CONCERN WITH ENERGY OUTPUT OF THEIR LIGHTSHEER DEVICE, WHEN 5-6 PTS REPORTED SUPERFICIAL-FIRST DEGREE BURNS AFTER HAIR REMOVAL TREATMENTS. ONLY ONE PT (CM) WAS PRESCRIBED MEDICATION FOR THE BURNS; THE OTHER PTS WERE RECOMMENDED TO APPLY BACITRACIN (OTC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ET LIGHTSHEER GEX LUMENIS INC. 50-05345 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention NONE RPEORTED.
    2 16 YR Required Intervention
    3 44 YR Required Intervention
    4 14 YR Required Intervention
    5 26 YR Required Intervention
    6 41 YR Required Intervention