BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACE

    MDR report key: 23350500 · Received October 21, 2025

    Report

    Report Number
    MW5177737
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    June 12, 2024
    Report Date
    October 16, 2025
    Manufacturer
    AESTHETICS BIOMEDICAL, INC.
    Product Code
    OUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD TWO ROUNDS OF VIVACE RF MICRONEEDLING UNDER MY CHIN THAT LEFT ME WITH HORRIFIC FAT LOSS THAT REQUIRED FAT GRAFTING AND SURGICAL CORRECTION, WHICH WAS ONLY PARTIALLY SUCCESSFUL. MY SURGEON SAYS MY SCAR TISSUE IS EXTENSIVE -- ONE OF THE WORST HE'S SEEN. MULTIPLE LAYERS OF MY SKIN AND FASCIA WERE ADHERED TO EACH OTHER VIA SCARRING. IT HAS COST $17,000+ TO CORRECT THE PERMANENT DAMAGE. IT IS PAINFUL. IT HAS COMPROMISED MY LYMPHATIC SYSTEM. IT TAKES MONTHS AND MONTHS FOR MY LYMPH NODES ON THE LEFT SIDE OF MY NECK TO DRAIN AFTER SURGERY OR ILLNESS AND THIS WAS NOT A PROBLEM I HAD UNTIL AFTER VICACE. I AM DOUBTFUL THAT MY NECK WILL EVER BE COMPLETELY CORRECTED. I'M HORRIBLY SELF-CONSCIOUS ABOUT IT AND IT HAS SIGNIFICANTLY IMPACTED MY MENTAL HEALTH AND SOCIALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730403 VIVACE SKIN RESURFACING RF APPLICATOR OUH AESTHETICS BIOMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other METFORMIN.| PRAZOSIN.| TIRZEPATIDE.| WELLBUTRIN.