BEUDAMED
    FDA Adverse Event Summary report: N

    LIGHTSHEER ET

    MDR report key: 2823025 · Received November 7, 2012

    Report

    Report Number
    1720381-2012-00059
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 7, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS BY PHONE AND EMAIL WERE MADE TO OBTAIN INFORMATION FROM THE USER FACILITY INCLUDING PATIENT INFORMATION, TREATMENT SETTINGS AND SUN EXPOSURE. THE PATIENT PHOTOGRAPHS WERE PROVIDED BY THE FACILITY; HOWEVER, ABSENT PATIENT TREATMENT SETTINGS AND SUN EXPOSURE INFORMATION NO DETERMINATION OF THE APPROPRIATENESS OF THE SETTINGS CAN BE MADE. LUMENIS IS UNABLE TO DETERMINE A CAUSE. A LUMENIS TECHNICAL ENGINEER COMPLETED PERFORMANCE TESTS OF ALL SPECIFICATIONS CONCLUDING THAT THE DEVICE OPERATED TO MANUFACTURER'S SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY THAT A PATIENT SUSTAINED SUPERFICIAL BURNS TO LEGS FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. NO INFORMATION REGARDING MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other