BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE ENCORE AESTHETIC PACKAGE

    MDR report key: 1082248 · Received July 24, 2008

    Report

    Report Number
    2914019-2008-00031
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    April 30, 2008
    Report Date
    July 24, 2008
    Manufacturer
    LUMENIS LTD TOKNEAM
    Product Code
    HQF
    PMA / PMN Number
    K020839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED BY/OR USER FACILITY. OBSERVED BY LUMENIS SERVICE INVESTIGATIONS. TREATMENT PARAMETERS WERE CONFIRMED TO BE WITHIN DFU THRESHOLDS. AS THIS IS THE FIRST REPORTED EVENT OF THIS TYPE AND RELATED PRODUCT TRENDING IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UP ENCORE TREATMENT, THE PT RECEIVED A 2MM X 1 CENTIMETER SCAR ON HER LEFT LOWER EYELID AND A 6MM X 1 CENTIMETER SCAR ON HER RIGHT LOWER EYELID. ALSO, THERE IS AN ECTROPIAN ON THE LEFT INNER CORNER OF HER EYE. THE PT HAS BEEN TREATED WITH STEROID INJECTIONS. VBEAM LASER AND SILICON GEL SHEETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE ENCORE AESTHETIC PACKAGE ULTRAPULSE ENCORE HQF LUMENIS LTD TOKNEAM 0642-415-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention