BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER SYSTEM

    MDR report key: 371624 · Received January 11, 2002

    Report

    Report Number
    2953684-2002-00001
    Event Type
    Other
    Date Received
    January 11, 2002
    Date of Event
    September 4, 2001
    Report Date
    December 14, 2001
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PATIENT HAD DEVELOPED BLISTERS AND HYPERPIGMENTATION FOLLOWING THE THIRD TREATMENT. TREATMENT WAS FOR HAIR REMOVAL ON THE LEGS. LUMENIS HAS BEEN UNABLE TO CONFIRM SERIOUSNESS OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SYSTEM LASER GEX LUMENIS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other