BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 835033 · Received April 3, 2007

    Report

    Report Number
    2914019-2006-00103
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    January 3, 2006
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LIGHTSHEER DEVICE WAS EVALUATED BY LUMENIS SERVICE. ON INITIAL INSPECTION, DIAGNOSTIC READINGS MET MANUFACTURING SPECIFICATIONS. SERVICE DEPOT CHECKED ENERGY METER GLASS AND IT WAS CLEAN. SERVICE DEPOT CHECKED THE SAPPHIRE TIP AND IT WAS CLEAN. THE FAN WAS NOISY AND WAS REPLACED, BUT THE FAN PROBLEM DOES NOT RELATE TO THE REPORTED SAFETY INCIDENT. SERVICE DEPOT PERFORMED ENERGY METER CALIBRATION. AS THE CUSTOMER DID NOT PROVIDE THE REQUESTED DETAILS INCLUDING TREATMENT PARAMETERS, IT IS NOT POSSIBLE TO DETERMINE WHETHER PT OR TREATMENT FACTORS ARE CONNECTED WITH THE ROOT CAUSE. NO ROOT CAUSE FOR THE INCIDENT COULD BE DETERMINED. IN THE ORIGINAL ANALYSIS, THIS COMPLAINT WAS CONSIDERED NOT TO BE MDR REPORTABLE. AN MDR IS NOW BEING FILED AS A RESULT OF THE FDA LETTER DATED 7/25/2006.

    Description of Event or Problem · 1

    SEVERAL (4) PTS RETURNED WITH HYPERFOLLICULATION, SWELLING AND BURNS (FIRST DEGREE) STARTING WITH TREATMENTS IN 2006. THESE PT'S WERE ALL TREATED ON RETURN VISITS AT THE USUAL SETTINGS. PT'S DENIED SUN EXPOSURE AND PHOTOSENSITIZING AGENTS. ALL 4 PT'S WERE SKIN TYPE II-III. MEDICAL INTERVENTION WAS REPORTED FOR ALL 4 PT'S. ALL 4 PT'S WERE PRESCRIBED KENALOG CREAM, AND ONE PT WAS PRESCRIBED ORAL ANTIBIOTIC (ERYTHROMYCIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER GEX LUMENIS, INC. LIGHTSHEER ET *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention NONE REPORTED
    2 * Required Intervention
    3 * Required Intervention