BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPILIGHT

    MDR report key: 624757 · Received August 5, 2005

    Report

    Report Number
    2914019-2005-00038
    Event Type
    Injury
    Date Received
    August 5, 2005
    Date of Event
    May 19, 2005
    Report Date
    August 4, 2005
    Manufacturer
    LUMENIS, (ISRAEL)
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT IS CLAIMING "SERIOUS PERSONAL INJURIES" IN ASSOCIATION WITH A 2005 EPILIGHT TREATMENT PERFORMED AT THE FACILITY. THE FACILITY STATED THAT THEY HAVE RECEIVED 2 DAYS OF CLINICAL EDUCATION AND THAT THEY HAVE NOT YET TREATED PAYING PATIENTS. IN 2005 LUMENIS NOTIFIED THE OFFICE MANAGER OF THE FACILITY BY TELEPHONE THAT LUMENIS RECOMMENDS THEY HAVE EPILIGHT UNIT SERVICED PRIOR TO USING IT FOR ADDITIONAL TREATMENTS. 2 DAYS EARLIER LUMENIS SENT A LETTER ADDRESSED TO THE MEDICAL DIRECTOR. THE FACILITY STATING THAT BASED ON THE LIMITED INFORMATION AVAILABLE , LUMENIS IS RECOMMENDING THAT THE SUBJECT EPILIGHT DEVICE NOT BE USED FOR ADDITIONAL TREATMENTS UNITL IT RECEIVES APPROPRIATE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILIGHT AESTHETIC LASER GEX LUMENIS, (ISRAEL) GA4100002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention