BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 3142953 · Received May 30, 2013

    Report

    Report Number
    3006560326-2013-00007
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    December 28, 2012
    Report Date
    May 28, 2013
    Manufacturer
    ULTHERA INC.
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PRACTICE: PATIENT WAS TREATED IN EARLY (B)(6). THE CLINICIAN USED LIDOCAINE WITH EPI INFILTRATIONS THROUGHOUT THE FACE AND NECK. SHE IS REPORTING BILATERAL SWELLING. ON (B)(6) 2013, BILATERAL SWELLING WAS REPORTED TO BE DIMINISHING. ON (B)(6) 2013, PRACTICE REPORTS: SHE STILL PRESENTS WITH HYPERPIGMENTATION AND INDENTED LINES ON THE NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238375 ULTHERA ULTHERA AESTHETIC ULTRASOUND SYSTEM GEI ULTHERA INC. UC-1

    Patients

    Seq Age Sex Outcome Treatment
    1