BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 1080973 · Received July 18, 2008

    Report

    Report Number
    2914019-2008-00029
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 18, 2008
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS QA EVAL OF THE SUSPECT DEVICE FOUND DRIED SUBSTANCE ON SURFACE OF SAPPHIRE TIP. EVAL FOUND THAT TIP HAD NOT BEEN PROPERLY MAINTAINED IN ACCORDANCE TO PRODUCT LABELING. THE MDR IS BEING FILED DUE TO DIRTY TIP IN COOPERATION WITH PENDING MANDATE FROM THE DISTRICT OFFICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY END-USER FACILITY THAT 3 PTS SUSTAINED BLISTERS/BRUISES AFTER HAIR REMOVAL TREATMENTS WITH LIGHTSHEER ET LASER SYS. REPORTED EVENTS ARE NOT EXPECTED TO BE PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER LIGHTSHEER ET GRAY DIODE LASER GEX LUMENIS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1