BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 1002866 · Received February 8, 2008

    Report

    Report Number
    2914019-2008-00002
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 29, 2008
    Manufacturer
    RH-USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS DETERMINED TO BE USER ERROR IN NOT MAINTAINING THE DEVICE. REGULATORY INSPECTION UPON ARRIVAL OF UNIT AT DEPOT FOUND A SPOT IN SAPPHIRE TIP AND SPOTS ON THE ENERGY METER GLASS. BOTH WERE CLEANED THOROUGHLY. AN MDR WILL BE FILED DUE TO MEDICAL INTERVENTION AND DIRTY TIP AS AGREED UPON WITH THE DISTRICT OFFICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 PATIENTS AND THE AESTHETICIAN EXPERIENCED WELTS AND BLISTERS FOLLOWING HAIR REMOVAL TREATMENT WITH LIGHTSHEER ET. ALL PERSONS HAD PREVIOUSLY TOLERATED THE SETTINGS USED ON THE INCIDENT DATE WITH NO PROBLEMS. PATIENT #2 IS FEMALE, SKIN TYPE II-III, WHO HAD HAIR REMOVAL TREATMENT ON HER UNDERARMS AND BIKINI AT 44J, 30MS AND 45J, 30MS, RESPECTIVELY. PATIENT NOTED THAT THE TREATMENT HURT MORE THAN USUAL. WITHIN 24 HOURS THE PATIENT REPORTED BLISTERS AND WELTS. PATIENT #2 WAS GIVEN STEROID CREAM. AS OF THE REPORT, PATIENT STILL HAS BROWN CIRCLES IN BIKINI AREA THAT ARE SLOWLY HEALING AND FADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SOLID STATE AESTHETIC LASER GEX RH-USA, INC. LIGHTSHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention