BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE AESTHETIC PACKAGE

    MDR report key: 1892347 · Received October 27, 2010

    Report

    Report Number
    2914019-2010-00048
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    March 23, 2009
    Report Date
    October 27, 2010
    Manufacturer
    LUMENIS LTD. YOKNEAM
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE TO OBTAIN TREATMENT SETTINGS, PT INFO, SUBJECT DEVICE SERIAL NUMBER, AND SERVICE HISTORY RECORDS FROM THE USER FACILITY, HOWEVER NONE WAS RECEIVED. A REVIEW OF SERVICE RECORDS CONCLUDED THE REPORTED USER FACILITY DID NOT OBTAIN THE SUBJECT DEVICE FROM LUMENIS DIRECTLY, NOR DOES THE FACILITY MAINTAIN A SERVICE CONTRACT WITH LUMENIS. WITHOUT THE SUBJECT DEVICE SERIAL NUMBER, LUMENIS IS UNABLE TO DETERMINE THE STATUS OF THE DEVICE. LUMENIS IS THEREFORE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. ALTHOUGH NO INFO WAS PROVIDED BY THE USER FACILITY ABOUT THE SERVICE HISTORY OF THE DEVICE, LUMENIS CANNOT RULE OUT THAT SERVICE BY AUTHORIZED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THEIR CLIENT SUSTAINED SERIOUS BURN INJURIES TO THE NECK AND CHEST, SHOCK, AND INJURIES TO THE NERVOUS SYSTEM, AFTER TREATMENT PERFORMED WITH A LUMENIS ULTRAPULSE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE AESTHETIC PACKAGE CARBON DIOXIDE SURGICAL LASER GEX LUMENIS LTD. YOKNEAM ENCORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other