BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 3876953 · Received June 17, 2014

    Report

    Report Number
    1720381-2014-00040
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 17, 2014
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS BY PHONE AND FAX WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE USER FACILITY FOR THE REPORTED EVENT INCLUDING PATIENT INFORMATION, PATIENT PHOTOGRAPHS, TREATMENT SETTINGS, SUN EXPOSURE AND TEST PATCH, HOWEVER NONE WAS RECEIVED OTHER THAN THE INITIAL REPORT. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT THE DEVICE REQUIRED CALIBRATION OF THE OUTPUT ENERGY. IT WAS FURTHER NOTED BY THE EXPERT THAT FOLLOWING CALIBRATION AND PREVENTATIVE MAINTENANCE OF THE DEVICE, ALL OUTPUTS ARE WITHIN MANUFACTURERS SPECIFICATIONS. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENTS REPORTED. THEREFORE; LUMENIS IS UNABLE TO EVALUATE TREATMENT PARAMETERS TO DETERMINE THEIR APPROPRIATENESS FOR TREATMENT AND TO DETERMINE A CAUSE. SHOULD MORE INFORMATION BE REPORTED A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY TO THE ARM FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. NO REPORT OF SERIOUS INJURY WAS INITIALLY RECEIVED AT THE TIME THE PATIENT EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354663 LIGHTSHEER ET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER ET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other