BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 6909706 · Received October 3, 2017

    Report

    Report Number
    3006560326-2017-00014
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    October 19, 2015
    Report Date
    November 30, 2015
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    UDI-DI
    00840763100223
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS IDENTIFIED AS BEING REPORTABLE AS A RESULT OF A REVIEW OF COMPLAINTS RECEIVED BY ULTHERA, INC. MERZ DEVICE INNOVATION CENTER. THIS SUBMISSION IS PART OF A CORRECTION DOCUMENTED IN ULTHERA, INC., MERZ DEVICE INNOVATION CENTER (B)(4). IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A MERZ FIELD REPRESENTATIVE CONVEYED THAT THEY RECEIVED A CALL FROM A PRACTICE WHO REPORTED A PATIENT EXPERIENCING EXTREME PARESIS FOLLOWING A FULL FACE ULTHERA TREATMENT WITH CONTROL UNIT SERIAL NUMBER (B)(4), PERFORMED UNDER STANDARD PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690646 ULTHERA SYSTEM ULTHERA SYSTEM OHV ULTHERA, INC., MERZ DEVICE INNOVATION CENTER UC-1 00840763100223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other