BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER

    MDR report key: 3481410 · Received August 15, 2013

    Report

    Report Number
    3004135191-2013-00056
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    March 17, 2012
    Report Date
    August 13, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE PATIENT'S REPORT CONTACTING ITS LOCAL AGENT, AN AUTHORIZED LUMENIS DISTRIBUTOR, IN THE COUNTRY. THE DISTRIBUTOR CONFIRMED THAT THE USER FACILITY HAD NOT PURCHASED THE SUBJECT DEVICE FROM THEM OR FROM AN AUTHORIZED LUMENIS RESELLER. THE DISTRIBUTOR INVESTIGATED THE EVENT REPORT CONTACTING THE USER FACILITY IN AN ATTEMPT TO OBTAIN, SUBJECT DEVICE SERIAL NUMBER, TREATMENT RECORDS AND LASER SERVICE HISTORY WHICH THE FACILITY DECLINED TO PROVIDE. TO THE BEST KNOWLEDGE OF LUMENIS, THE DEVICE WAS PURCHASED FROM AN UNAUTHORIZED THIRD-PARTY SELLER. THE USER FACILITY DECLINED SERVICE FOR THE SUBJECT DEVICE THEREFORE, NO EXAMINATION OF THE PERFORMANCE OF THE DEVICE OCCURRED. LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENTS. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. A LUMENIS MEDICAL EXPERT REVIEWED THE PATIENT-PROVIDED PHOTOGRAPHS CONCLUDING THE PATIENT SUSTAINED POST-INFLAMMATORY HYPERPIGMENTATION. THE ADVERSE OUTCOME IS REPORTED TO HAVE BEEN PRESENT FOR MORE THAN 30-DAYS. LUMENIS IS UNABLE TO DETERMINE A CAUSE FOR THE PATIENT'S ADVERSE TREATMENT OUTCOME ABSENT DEVICE SERVICE RECORDS, DEVICE EXAMINATION, AND PATIENT TREATMENT SETTINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT IN (B)(6) THAT THEY SUSTAINED SCARRING FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER LASER. THE PATIENT SUPPLIED PHOTOGRAPHS AND A RECORD OF TREATMENT DATES FROM THE TREATING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395788 LIGHTSHEER SOLID STATE AESTHETIC LASER DELIVERY DEVICE, GEX GEX LUMENIS, LTD. LIGHTSHEER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other