BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACE RADIO FREQUENCY MICRONEEDLING

    MDR report key: 24888430 · Received April 15, 2026

    Report

    Report Number
    MW5186875
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    November 18, 2021
    Report Date
    April 10, 2026
    Manufacturer
    AESTHETICS BIOMEDICAL INC.
    Product Code
    OUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    NERVE DAMAGE VASCULAR DAMAGE DRY EYE DEFORMATION PTOSIS. ESTHETICIAN WENT AROUND MY EYE SOCKET AT 1.5 AND HIGH HEAT. MY JAW LOCKED TONGUE FELT WEIRD VESSEL IN TEMPLE POUNDING EYE BURNING EAR NERVE PAIN LOWER BACK OF SKULL SCALP TEMPLE EYE PAIN EYE SWELLING. IT'S BEEN 4 YRS AND THE PAIN COMES AND GOES. I LIFT HEAVY WEIGHTS AND MY TEMPLE HURTS AND MY EYE SWELLS. I HAVE A VISIBLE DENT OF FAT LOSS ON INNER EYES ONE WORSE THAN OTHER. I GOT DIAGNOSED WITH TRIGENERAL NEURALGIA AND BELL'S PALSY DRY EYE BURNS AFTER RADIO FREQUENCY MICRONEEDLING DONE BY AN ESTHETICIAN THAT WENT AROUND MY EYE WITH NO SR SUPERVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948985 VIVACE RADIO FREQUENCY MICRONEEDLING SKIN RESURFACING RF APPLICATOR OUH AESTHETICS BIOMEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other