BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 2557295 · Received May 2, 2012

    Report

    Report Number
    3004135191-2012-00030
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 2, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE PROBABLE ROOT CAUSE OF THE REPORTED EVENT TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE DEVICE OPERATOR IN CONTRADICTION TO DEVICE LABELING AND COMMON MEDICAL PRACTICE. FURTHERMORE, THE EXPERT CONCLUDED THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS SUSTAINED SUPERFICIAL BURNS TO THE JAWLINE AND THIGH AREA RESPECTIVELY FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. IT WAS FURTHER REPORTED THAT THE PATIENTS HAVE HEALED. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR ANY MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other