BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULIGHT HR

    MDR report key: 2420460 · Received January 18, 2012

    Report

    Report Number
    3004135191-2012-00003
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    April 27, 2011
    Report Date
    January 18, 2012
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K020839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED SERVICE OF THE SUBJECT DEVICE BY LUMENIS TECHNICAL REPRESENTATIVE. LUMENIS HAS NOT HELD A SERVICE CONTRACT WITH THE USER FACILITY FROM (B)(4) 2002 AND HAS NOT SERVICED THE DEVICE SINCE (B)(4) 2010. LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENTS PHOTOGRAPHS CONCLUDING THE PROBABLE CAUSE TO BE EXCESSIVE TREATMENT SETTINGS EMPLOYED IN CONTRADICTION TO DEVICE TRAINING AND COMMON MEDICAL PRACTICE. THE USER FACILITY DECLINED SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SECOND DEGREE BURN TO THE CHEST WHICH RESULTED IN A SMALL SCAR FOLLOWING IPL TREATMENT WITH A LUMENIS VASCULIGHT HR LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT HR INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS LTD VASCULIGHT HR

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other