BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE

    MDR report key: 2972597 · Received February 21, 2013

    Report

    Report Number
    3004135191-2013-00018
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 21, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K022060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE USER FACILITY TO OBTAIN PATIENT TREATMENT SETTINGS, PATIENT PHOTOGRAPHS AND OTHER RELEVANT INFORMATION WHICH WERE PROVIDED. NO DEVICE MALFUNCTION WAS REPORTED TO LUMENIS AT THIS TIME OR IS SUSPECTED OF BEING THE CAUSE OF THE EVENT REPORTED HEREWITH; THEREFORE, NO SUBJECT DEVICE EXAMINATION OCCURRED. A LUMENIS AESTHETIC CLINICAL DIRECTOR AND PHYSICIAN-EXPERT IN THE USE OF THE SUBJECT DEVICE CONCLUDED, "THIS PATIENT REPRESENTS AN AGGRESSIVE TREATMENT WITH HEALING AND POST TREATMENT PROPORTIONAL TO THE AGGRESSIVENESS OF THE TREATMENT. THE PATIENT WILL PROBABLY HAVE AN EXCELLENT RESULT. SHE MAY BE AT SOME RISK FOR HYPO PIGMENTATION BUT IT IS TOO EARLY TO TELL. POST-OPERATIVE TREATMENT WITH THE PDL (PULSED DYE LASER) IS FINE TO DECREASE THE ERYTHEMA. I WOULD RECOMMEND TOPICAL TRIAMCINALONE OINTMENT AS WELL." THIS REPORT IS BEING FILED BECAUSE THE PATIENT'S ADVERSE OUTCOME MAY REQUIRE FURTHER MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED ADVERSE TREATMENT COMPLICATIONS RELATED TO AGGRESSIVE SETTINGS EMPLOYED DURING TREATMENT TO THE FACE WITH A LUMENIS ULTRAPULSE ENCORE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75492 ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASER DELIVERY DEVICE GEX LUMENIS, LTD. ULTRAPULSE ENCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other