BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 1667611 · Received April 23, 2010

    Report

    Report Number
    2914019-2010-00021
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 23, 2010
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THAT THE REPORTED NUMBER OF PASSES PERFORMED BY THE DEVICE OPERATOR WERE EXCESSIVE AND IN CONTRAINDICATION TO THE COMMON PRACTICE FOR THE SUBJECT INDICATION. FOLLOW UP TRAINING OF THE USER FACILITY BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT WAS COMPLETED TO PRECLUDE EVENT RECURRENCE. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST CONFIRMED THAT NO RELATED DEVICE MALFUNCTION OCCURRED AND THAT THE DEVICE PERFORMED WITHIN MANUFACTURED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED FIRST DEGREE BURNS ON THE SHIN RESULTING IN HYPOPIGMENTATION, AFTER HAIR REMOVAL TREATMENT WITH THE HIGHSPEED HANDPIECE OF A LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED BY THE USER FACILITY THAT THE DEVICE OPERATOR EMPLOYED EXCESS PASSES OVER THE SAME TREATMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER DUET DIODE GEX RH USA, INC. GASB00002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR