BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACE

    MDR report key: 10857615 · Received November 17, 2020

    Report

    Report Number
    3012204368-2020-00001
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    March 3, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SHENB
    Product Code
    OUH
    UDI-DI
    08800017100326
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED FACIAL TREATMENTS OF FILLER AND NEUROMODULATORS 4 WEEKS PRIOR TO THE VIVACE TREATMENT. THE TREATMENT RESULTED IN THE FILLER AND NEUROMODULATORS MELTING AWAY, LEAVING THE PATIENT'S FACE SAGGING. THE PROVIDER HAD PLANNED A SERIES OF TREATMENTS WITH THE VIVACE DEVICE AND INCLUDED A TREATMENT FOR INJECTIONS BETWEEN THE FIRST AND SECOND VIVACE TREATMENTS. VIVACE TREATMENT ONE WAS PERFORMED ON (B)(6) 2020. THE FILLER INJECTIONS WERE PERFORMED (B)(6) 2020. THE SECOND VIVACE TREATMENT WAS THE SUBJECT OF THIS REPORT, PERFORMED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315062 VIVACE RADIOFREQUENCY MICRONEEDLING SYSTEM OUH SHENB VIVACE 08800017100326

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other BOTOX - ALLERGAN, VERSA HA FILLER - REVANESSE.