BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER

    MDR report key: 731560 · Received June 29, 2006

    Report

    Report Number
    2914019-2006-00056
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    March 14, 2006
    Report Date
    June 29, 2006
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON NEW INFORMATION FROM A LUMENIS ENGINEER WE HAVE DETERMINED THIS IS A POSSIBLE DEVICE MALFUNCTION AND MDR IS BEING FILED. FUTHER INVESTIGATION IS ANTICIPATED AND A FOLLOW-UP MDR WILL BE FILED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED TO LUMENIS ON 05/25/2006. IN 2006 A PATIENT EXPERIENCED RED "WIELS" WITHOUT BLISTERS DURING THE SECOND LIGHTSHEER HAIR REMOVAL TREATMENT TO THE LEGS. PATIENT TREATED TO LEGS AT 28 JOULES, 30 MS, APPROXIMATELY 1200 PULSES TOTAL ON LEFT AND RIGHT LEGS; TREATED RIGHT LEG FIRST AND PATIENT DEVELOPED RED "WIELS" AND FLUENCE WAS DROPPED TO 26 JOULES FOR REMAINDER OF THE TREATMENT. WHERE TREATED AT 26 JOULES, THE PATIENT HAD SAME REACTION AS FIRST LIGHTSHEER TREATMENT TO LEGS 34 DAYS AGO: RED WITH ERYTHEMA ONLY, NO BURNS. PATIENT WAS ALSO TREATED TO AXILLA AND BIKINI 34 DAYS LATER, THESE AREAS REACTED MORE THAN ON THE FIRST TREATMENT, BUT WITH ERYTHEMA ONLY, NO BURNS. THE LEGS HEALED WITH HYPOPIGMENTATION IN THE LOCATIONS OF THE RED "WIELS". PHYSICIAN EXAMINED THE PATIENT AND FELT THAT THE PATIENT WOULD HEAL WITHOUT PROBLEMS, THE AREAS OF HYPOPIGMENTATION WOULD HEAL AND RETURN TO NORMAL SKIN COLOR, BUT ADVISED PATIENT THAT THIS PROCESS COULD TAKE WEEKS OR MONTHS. ADVISED TO STAY OUT OF SUN, USE SUNSCREEN. ONLY OTC PRODUCTS WERE REPROTED USED BY THE PATIENT. LUMENIS RECOMMENDED DEPROT SERVICE FOR THE CUSTOMER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SOLID STATE AESTHETIC LASER GEX LUMENIS LIGHTSHEER ET *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR