BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 2250225 · Received September 15, 2011

    Report

    Report Number
    1720381-2011-00048
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 15, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPHS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE. THE HEALTHCARE PROFESSIONAL CONCLUDED POOR TREATMENT TECHNIQUE TO BE THE ROOT CAUSE OF THE EVENT REPORTED. FURTHERMORE, THE EXPERT CONCLUDED THE BURN WOULD LIKELY RESULT IN A SCAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A BURN TO THE ANKLE FOLLOWING TREATMENT WITH THE LUMENIS LIGHTSHEER DUET LASER. 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: DIODE GEX LUMENIS, INC. DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other