BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULIGHT SR

    MDR report key: 2494324 · Received March 16, 2012

    Report

    Report Number
    3004135191-2012-00014
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    December 20, 2011
    Report Date
    March 16, 2012
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K020839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE BY LUMENIS TO OBTAIN RELEVANT TREATMENT INFORMATION, PATIENTS' PHOTOGRAPHS, AND PATIENTS' INFORMATION FROM THE USER FACILITY; HOWEVER, NO INFORMATION OTHER THAN THE INITIAL REPORT WAS RECEIVED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SPECIALIST FOUND THAT THE DEVICE PERFORMED TO MANUFACTURER'S SPECIFICATIONS. DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENTS REPORTED. LUMENIS IS UNABLE TO DETERMINE A CAUSE BASED ON THE INFORMATION PROVIDED. SHOULD FURTHER INFORMATION BE PROVIDED, LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LETTER TO LUMENIS THAT THREE PATIENTS "SUSTAINED TISSUE INJURIES BEYOND WHAT WOULD NORMALLY BE EXPECTED AND WERE EVALUATED AND TREATED BY A PHYSICIAN" FOLLOWING TREATMENT WITH A LUMENIS VASCULIGHT SR LASER. IT WAS FURTHER REPORTED THAT ONE OF THE THREE PATIENTS SUSTAINED A BURN AND SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT SR SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS LTD SR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other