BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER

    MDR report key: 1397490 · Received June 2, 2009

    Report

    Report Number
    2914019-2009-00031
    Event Type
    Injury
    Date Received
    June 2, 2009
    Date of Event
    April 28, 2009
    Report Date
    May 28, 2009
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. LUMENIS MEDICAL STAFF EVALUATED THE REPORTED SETTINGS AND DETERMINED AGGRESSIVE SETTINGS TO BE THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 PATIENTS SUSTAINED SECOND DEGREE BURNS AFTER HAIR REMOVAL TREATMENT.

    Additional Manufacturer Narrative · 2

    A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. LUMENIS MEDICAL STAFF EVALUATED THE REPORTED SETTINGS AND DETERMINED AGGRESSIVE SETTINGS TO BE THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS.

    Description of Event or Problem · 2

    IT WAS REPORTED THAT 4 PATIENTS SUSTAINED SECOND DEGREE BURNS AFTER HAIR REMOVAL TREATMENT.

    Additional Manufacturer Narrative · 3

    A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. LUMENIS MEDICAL STAFF EVALUATED THE REPORTED SETTINGS AND DETERMINED AGGRESSIVE SETTINGS TO BE THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS.

    Description of Event or Problem · 3

    IT WAS REPORTED THAT 4 PATIENTS SUSTAINED SECOND DEGREE BURNS AFTER HAIR REMOVAL TREATMENT.

    Additional Manufacturer Narrative · 4

    A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE SUBJECT DEVICE WAS WITHIN ALLOWABLE OPERATING AND FUNCTIONAL TOLERANCES. NO RELATED DEVICE MALFUNCTION WAS OBSERVED. LUMENIS MEDICAL STAFF EVALUATED THE REPORTED SETTINGS AND DETERMINED AGGRESSIVE SETTINGS TO BE THE PROBABLE ROOT CAUSE OF THE REPORTED EVENTS.

    Description of Event or Problem · 4

    IT WAS REPORTED THAT 4 PATIENTS SUSTAINED SECOND DEGREE BURNS AFTER HAIR REMOVAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LUME1 HP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other
    2 52 YR Other
    3 37 YR Other
    4 38 YR Other