BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 481848 · Received September 2, 2003

    Report

    Report Number
    2953684-2003-00002
    Event Type
    Other
    Date Received
    September 2, 2003
    Date of Event
    July 9, 2002
    Report Date
    September 2, 2003
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN 2003, LUMENIS WAS NOTIFIED OF THE FOLLOWING LEGAL COMPLAINT - PATIENT CLAIMS TO HAVE EXPERIENCED BURNS ON THEIR FACE AFTER UNDERGOING LASER HAIR REMOVAL TREATMENT IN 2002. IT IS SPECIFIED IN THE COMPLAINT THAT ONE DOCTOR DEFINED THE BURN AS FIRST DEGREE, ANOTHER DOCTOR DEFINED THE BURN AS FIRST DEGREE, ANOTHER DOCTOR DEFINED THE BURN AS INTERMEDIATE & SUPERFICIAL 2ND DEGREE AND THIRD DEFINED AS HYPERPIGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SURGICAL LASERS GEX LUMENIS, INC. 50-03745-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other