REVANESSE VERSA + (WITH LIDOCAINE) 1.2 ML
Received Apr 28, 2025 · Event occurred Feb 26, 2025
Report 3004423487-2025-00010 · MDR key 21921911
Device
Generic name
Revanesse Versa +
Manufacturer
Prollenium Medical Technologies Inc.Model number
40083Lot number
24B034
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
46 YR · Female
- Discomfort
- Discomfort
Narrative
Description of Event or Problem
PATIENT CAME IN REQUESTING LIP FILLER. INJECTOR ADVISED SHE DISSOLVE, BUT PATIENT REQUESTED JUST ENOUGH TO ADD HYDRATION. INJECTOR USED .2CC ON REVANESSE LIPS+ ON TOP RIGHT PILLOW ON LOWER RIGHT PILLOW AND ADDED .1CC TO PIRIFORM FOSSA ON EACH SIDE. PATIENT CALLED LAST NIGHT SAYING SHE HAS HAD BURNING SENSATION SINCE INJECTION (ONE MONTH PRIOR IE. (B)(6) 2025). SHE DID NOT REPORT BECAUSE SHE THOUGHT IT WOULD IMPROVE, BUT HER LIPS STILL BURN, AND SHE HAS SOME PAIN WHEN APPLYING CHAPSTICK. PATIENT FEELS SHE IS SEEING SOME WHITENESS, BUT PROVIDER BELIEVES BEFORE AND AFTER COLOR IS CONSISTENT BASED ON PHOTOS (NOT PROVIDED BY THE CLINIC). EVENT REPORTED ON 28-MAR-2025. INTERNAL REPORT NUMBER: CCR-C-2512.