BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2421856 · Received January 19, 2012

    Report

    Report Number
    1720381-2012-00004
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 20, 2011
    Manufacturer
    LUMENIS INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. CALIBRATION WAS FOUND TO BE WITHIN ACCEPTABLE LIMITS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE PROBABLE CAUSE OF THE EVENTS TO BE FAILURE TO PERFORM A TEST PATCH TO DETERMINE APPROPRIATE TREATMENT SETTINGS PRIOR TO TREATMENT IN CONTRADICTION TO DEVICE LABELING, TRAINING, AND COMMON MEDICAL PRACTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED SECOND DEGREE BURNS TO THE NECK AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER. NO TEST PATCH WAS REPORTEDLY PERFORMED ON THE PATIENTS PRIOR TO TREATMENT. NO MEDICAL INTERVENTION WAS REPORTED TO PRECLUDE PERMANENT IMPAIRMENT.

    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 Other