BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELLEVE S5

    MDR report key: 5563749 · Received April 8, 2016

    Report

    Report Number
    2428235-2016-00006
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 7, 2016
    Report Date
    April 8, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K123366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS ONLY INTENDED FOR FACIAL WRINKLES AND RHYTIDS. IT COULD NOT BE DETERMINED IF DEVICE CAUSED THE SWELLING OF THE LYMPH NODE. THE CUSTOMER HAS STATED THAT THE SWELLING WENT DOWN AND PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    PATIENT TREATED UNDER CHIN AREA WITH PELLEVE. A 1 - 1/2 HOURS POST TREATMENT PATIENT DEVELOPED A SMALL LUMP WITH SWELLING AND PALPABLE LYMPH GLAND. PRESCRIBED MOTRIN AND FOLLOW UP WITH ENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218218 PELLEVE S5 PELLEVE S5 GEI CYNOSURE, INC. DBA ELLMAN IEC5P-ST/110-USA (MOD2)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other