BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 806223 · Received January 5, 2007

    Report

    Report Number
    2914019-2006-00113
    Event Type
    Other
    Date Received
    January 5, 2007
    Date of Event
    December 7, 2006
    Report Date
    January 5, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 01/05/2007, DEVICE EVALUATION BY THE LUMENIS SERVICE DEPOT IS IN PROCESS. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH DEVICE EVALUATION RESULTS AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 1

    PER THE CUSTOMER, THE PHYSICIAN USED LOW SETTINGS DURING TREATMENTS, BUT THREE PTS WERE STILL BURNED FOLLOWING LIGHTSHEER HAIR REMOVAL TREATMENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE PENDING EVALUATION BY LUMENIS SERVICE. ON 12/19/2006, THE CUSTOMER REPORTED THAT, THE BURNS WERE AT MOST FIRST DEGREE AND HAD RESOLVED, AND THAT ONE OF THE THREE PTS HAD BEEN GIVEN BLEACHING CREAM (HYDROQUINONE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) OTHER GEX LUMENIS, INC. LIGHTSHEER FP *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other NONE REPORTED.