BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPILIGHT

    MDR report key: 806217 · Received January 8, 2007

    Report

    Report Number
    2914019-2005-00095
    Event Type
    Other
    Date Received
    January 8, 2007
    Report Date
    January 8, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVAL WAS POSSIBLE. LUMENIS HAS NO RECORD OF THE PHYSICIAN AS A LUMENIS CUSTOMER. THE SUBJECT DEVICE APPEARS TO BE AN EPILIGHT DEVICE, BUT BASED ON THE LIMITED DETAILS AVAILABLE, LUMENIS COULD NOT CONFIRM EITHER THE DEVICE MODEL OR THE SERIAL NUMBER. LUMENIS HAS REQUESTED THE DEVICE FACTS AND INCIDENT DETAILS THROUGH DISCOVERY. IF LUMENIS OBTAINS SIGNIFICANT ADDITONAL DETAILS IN THE FUTURE, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    AN ATTORNEY REPRESENTING A PHYSICIAN REPORTED AN INCIDENT THOUGHT BY THE ATTORNEY TO HAVE OCCURRED IN 2003 IN CONNECTION WITH AN EPILIGHT DEVICE. THE ATTORNEY MENTIONED "ARM BURNS AND/OR SUNTAN RESULTING IN BURNS." THE ATTORNEY AGREED TO PROVIDED PATIENT, DEVICE AND INCIDENT DETAILS TO LUMENIS, BUT DID NOT PROVIDE THESE DETAILS TO LUMENIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILIGHT AESTHETIC LASER GEX LUMENIS LTD UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other RNP REQUESTED AND NOT PROVIDED