VIVACE
Received Oct 21, 2025 · Event occurred Jun 12, 2024
Report MW5177737 · MDR key 23350500
Device
Generic name
Skin Resurfacing Rf Applicator
Manufacturer
Aesthetics Biomedical, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR · Female
- Emotional Changes
- Device Overstimulation of Tissue
- Pain
- Scar Tissue
- Unspecified Blood or Lymphatic problem
- Emotional Changes
- Device Overstimulation of Tissue
- Pain
- Scar Tissue
- Unspecified Blood or Lymphatic problem
Narrative
Description of Event or Problem
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.