BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELOS PLUS

    MDR report key: 6022626 · Received October 12, 2016

    Report

    Report Number
    3004772125-2016-00022
    Event Type
    Injury
    Date Received
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    GEX
    PMA / PMN Number
    K113868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEP. 2016 - RTC CARD WAS RETURNED TO SYNERON FOR INVESTIGATION. OCT 2016- INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    ON SEPTEMBER 13, 2016, SYNERON RA WAS MADE AWARE OF POSSIBLE ADVERSE EVENT FOLLOWING TREATMENT WITH ELOS PLUS SYSTEM AND SUBLIME APPLICATOR AT THE (B)(6). INCIDENT DATE IS UNKNOWN AT THIS POINT. FEMALE PATIENT UNDERWENT TREATMENT ON NECK AREA AND SUSTAINED SHOCKING SENSATION THAT CAUSED TWO LOCALIZED BURNS ON THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675337 ELOS PLUS EPLUS SKIN TREATMENT SYSTEM GEX SYNERON MEDICAL LTD. FG70532US

    Patients

    Seq Age Sex Outcome Treatment
    1 0000 YR