BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 1910558 · Received November 19, 2010

    Report

    Report Number
    1720381-2010-00055
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 19, 2010
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THAT NO RELATED DEVICE MALFUNCTION OCCURRED. NO DEVICE MALFUNCTION WAS REPORTED. REASONABLE ATTEMPTS WERE MADE BY PHONE AND E-MAIL TO OBTAIN TREATMENT PARAMETERS AND PATIENT SKIN TYPE FROM THE USER FACILITY, HOWEVER, NO INFORMATION WAS RECEIVED. CONSEQUENTLY, LUMENIS IS UNABLE TO DETERMINE A ROOT CAUSE. SHOULD ADDITIONAL INFORMATION BE PROVIDED BY THE USER FACILITY LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS SUSTAINED HYPOPIGMENTATION FOLLOWING TREATMENT WITH THE LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED BY THE USER FACILITY THAT SOME PATIENTS DO NOT FOLLOW APPROPRIATE AFTER CARE PROCEDURES FOR PREVENTING EXPOSURE TO SUNLIGHT AS OUTLINED IN DFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER DELIVERY DEVICE: DIODE GEX RH USA, INC. DUET

    Patients

    Seq Age Sex Outcome Treatment
    1