BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 648770 · Received December 2, 2005

    Report

    Report Number
    2914019-2005-00050
    Event Type
    Other
    Date Received
    December 2, 2005
    Report Date
    December 2, 2005
    Manufacturer
    LUMENIS (SANTA CLARA)
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CONTACTED THE BOARD OF DR'S ALLEGING INJURIES, THE NATURE OF WHICH HAVE NOT BEEN DISCLOSED TO LUMENIS, IN ASSOCIATION WITH LIGHT SHEER TREATMENT RECEIVED IN THE OFFICE OF MD. THE BOARD OF DR'S REPORTED THIS COMPLAINT TO LUMENIS. PER LUMENIS RECORDS, DR OWNS 3 LIGHTSHEER SYSTEMS; THERE HAVE BEEN NO PRIOR SAFETY COMPLAINTS REPORTED BY THE CUSTOMER IN ASSOCIATION WITH THESE 3 LIGHTSHEER SYSTEMS. LUMENIS HAS REQUESTED FROM DR THE SERIAL NUMBER OF THE ACTUAL SYSTEM INVOLVED IN THIS COMPLAINT IN ORDER TO PROGRESS THIS SAFETY COMPLAINT INVESTIGATION. AN MDR IS BEING FILED AT THIS TIME BECAUSE LUMENIS HAS BEEN UNABLE TO CONFIRM THE NATURE AND SEVERITY OF THE ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SURGICAL LASERS GEX LUMENIS (SANTA CLARA) NOT REPORTED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other