BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER SYSTEM

    MDR report key: 243352 · Received October 1, 1999

    Report

    Report Number
    2914019-1999-00004
    Event Type
    Other
    Date Received
    October 1, 1999
    Report Date
    September 6, 1999
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATE OF EVENT: WEEK OF JULY 19TH THROUGH JULY 24TH. EXACT DATE UNK. DOCTOR'S INITIAL LETTER ALLEGED PT RECEIVED BURNS, TWO SERIOUS. THE FIELD SERVICE ENGINEERING FOUND THE DELIVERED ENERGY WAS HIGHER THAN THE DISPLAYED ENERGY. FURTHER INVESTIGATION REVEALS FIRST AND SECOND DEGREE BURNS. THE BURNS HAVE HEALED, NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SYSTEM LASER GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other