BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS, INC.

    MDR report key: 1138634 · Received August 25, 2008

    Report

    Report Number
    2914019-2008-00039
    Event Type
    Injury
    Date Received
    August 25, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 21, 2008
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE INVESTIGATION FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. DEVICE RECEIVED STANDARD PREVENTATIVE MAINTENANCE ROUTING INCLUDING RECALIBRATION AND TESTED FINE. NO FAILURE MODE COULD BE FOUND WITH THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT SUSTAINED A SMALL SECOND DEGREE BURN AS A RESULT OF AN IPL TREATMENT TO THE FACE. TOPICAL BACITRACIN AND ATTABZX OINTMENTS WERE PRESCRIBED. PT WAS REPORTED TO HAVE FULLY RECOVERED WITHOUT ANY SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS, INC. LUMENIS ONE GEX LUMENIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention