BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 3735330 · Received April 9, 2014

    Report

    Report Number
    1720381-2014-00021
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 8, 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 EVENTS INCLUDING PATIENT INFORMATION, 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

    IT WAS REPORTED THAT THREE (3) PATIENTS SUSTAINED BURNS OF UNKNOWN SEVERITY TO THE LEGS AND NECK AREA RESPECTIVELY FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213767 LIGHTSHEER ET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER ET

    Patients

    Seq Age Sex Outcome Treatment
    1 Other