BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 1975819 · Received January 26, 2011

    Report

    Report Number
    1720381-2011-00002
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 26, 2011
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE TO OBTAIN PHOTOGRAPHS OF THE ADVERSE OUTCOMES; HOWEVER, NONE WERE RECEIVED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE PERFORMED WITHIN MANUFACTURED SPECIFICATIONS. PROBABLE CAUSE CAN BE ATTRIBUTED TO LEARNING CURVE WITH A NEW DEVICE. AN EVALUATION OF THE REPORTED EVENT DETAILS INCLUDING, TREATMENT SETTINGS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THAT THE SETTINGS WERE WITHIN ACCEPTABLE LIMITS PER DEVICE LABELING AND COMMON MEDICAL PRACTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED HYPOPIGMENTED LINES FOLLOWING HAIR REMOVAL TREATMENT WITH THE LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED, THE PATIENTS HAD SELF-TREATED THE INITIAL ADVERSE REACTION BEFORE REPORTING TO THE FACILITY ON F/U VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR