BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2471284 · Received February 28, 2012

    Report

    Report Number
    1720381-2012-00010
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    November 14, 2011
    Report Date
    February 28, 2012
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS-TRAINED TECHNICAL SPECIALIST FOUND THAT THE DEVICE FUNCTIONED TO MANUFACTURER SPECIFICATIONS AND THAT THE REPORTED EVENT COULD NOT BE DUPLICATED. REASONABLE ATTEMPTS BY PHONE AND EMAIL WERE MADE TO OBTAIN PATIENT PHOTOS WITH WHICH TO MAKE A COMPLETE ASSESSMENT OF THE REPORTED OUTCOME, HOWEVER THEY WERE NOT RECEIVED. A REVIEW OF THE REPORTED TREATMENT SETTINGS BY A LUMENIS HEALTHCARE PROFESSIONAL CONCLUDED THE PROBABLE ROOT CAUSE OF THE EVENT REPORTED TO BE AGGRESSIVE TREATMENT SETTINGS EMPLOYED FOR THE REPORTED PATIENT SKIN TYPE AND ANATOMICAL AREA TREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SECOND DEGREE BURN TO THE SHIN FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED THE PATIENT RETURNED TO THE USER FACILITY WITH A SMALL SCAR AND WAS SEEKING COMPENSATION. IT WAS FURTHER REPORTED THAT THE SYSTEM PRODUCED A "LARGE ENERGY OUTPUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS INC. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other