BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 851306 · Received May 8, 2007

    Report

    Report Number
    2914019-2001-00003
    Event Type
    Other
    Date Received
    May 8, 2007
    Date of Event
    May 12, 2001
    Report Date
    May 8, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS REGULATORY BELIEVES THAT THE SUBJECT LIGHTSHEER DEVICE IS LIGHTSHEER XC, BUT HAS NOT BEEN ABLE TO CONFIRM THIS INFO AS OF 3/20/2007. THIS COMPLAINT WAS PREVIOUSLY CLOSED UNTIL SUCH TIME AS ADD'L INCIDENT AND DEVICE DETAILS CAN BE OBTAINED BY LUMENIS THROUGH THE LEGAL DISCOVERY PROCESS.

    Description of Event or Problem · 1

    PER LEGAL PROCEEDINGS PROVIDED TO LUMENIS LEGAL DEPARTMENT, A PT ALLEGES THAT SHE SUSTAINED SEVERAL BURNS TO HER LEGS DURING A HAIR REMOVAL PROCEDURE AT THE ENDUSER LOCATION. NO OTHER DETAILS, INCLUDING THE SEVERITY OF THE BURNS, ANY MEDICAL INTERVENTION THAT MAY HAVE BEEN PROVIDED TO THE PT OR THE PT'S PROGNOSIS, WERE PROVIDED TO LUMENIS REGULATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER GEX LUMENIS, INC. LIGHTSHEAR XC 3376

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other