BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTHERA SYSTEM

    MDR report key: 6679468 · Received June 29, 2017

    Report

    Report Number
    3006560326-2017-00010
    Event Type
    Injury
    Date Received
    June 29, 2017
    Report Date
    June 4, 2017
    Manufacturer
    ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
    Product Code
    OHV
    PMA / PMN Number
    K134032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SOCIAL MEDIA MONITORING COMPANY, EVOLVE MKD, FOLLOWED UP WITH THE FACEBOOK USER ON 06-SEP-2017 TO PROVIDE THEM WITH CONTACT INFORMATION TO REPORT AN ADVERSE EVENT. EVOLVE MKD REPORTED ON 06-SEP-2017 THAT THE FACEBOOK USER STATED THE FOLLOWING IN RESPONSE TO THEIR COMMENT : "WHAT INQUIRY? I POSTED MY PERSONAL OPINION AND FAMILY ISSUE WITH YOUR PRODUCT. PERIOD." NO ADDITIONAL INFORMATION REGARDING THE EVENT, THE HEALTHCARE PROVIDER, OR THE DEVICES USED DURING THE TREATMENT WERE PROVIDED. THERE ARE NOT ENOUGH DETAILS TO CONFIRM WHETHER A MERZ/ULTHERA DEVICE MALFUNCTIONED. IN REFERENCE TO THE ALLEGED RETINAL NERVE DAMAGE, THE DEEPEST TREATMENT DEPTH OF TRANSDUCERS IS 4.5MM, WHICH MAKES DELIVERY TO RETINAL NERVE FIBERS IMPROBABLE. IT IS UNLIKELY THAT A MERZ/ULTHERA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. NO ADDITIONAL INVESTIGATION OR CORRECTIVE ACTIONS ARE WARRANTED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE SERIAL NUMBER UNKNOWN.

    Description of Event or Problem · 1

    A PATIENT'S FAMILY MEMBER REPORTED VIA A PUBLIC SOCIAL MEDIA POSTING THAT A FAMILY MEMBER EXPERIENCED RETINAL NERVE DAMAGE AFTER RECEIVING ULTHERAPY TREATMENT (SERIAL NUMBER NOT PROVIDED, TREATMENT PROVIDER NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457301 ULTHERA SYSTEM ULTHERA SYSTEM OHV ULTHERA, INC., MERZ DEVICE INNOVATION CENTER UC-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other