BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA

    MDR report key: 2801012 · Received October 18, 2012

    Report

    Report Number
    3006560326-2012-00013
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    April 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    .
    Product Code
    GEI
    PMA / PMN Number
    072505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTS: SUPERFICIAL VESSEL COLLAPSE AFTER TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1