InjuryLMH
REVANESSE VERSA+ (WITH LIDOCAINE)
Received Nov 12, 2025 · Event occurred Oct 9, 2025
Report 3004423487-2025-00022 · MDR key 23533999
Device
Generic name
Implant, Dermal, For Aesthetic Use
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40083Lot number
24I123
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR · Female
- Nodule
- Nodule
Narrative
Description of Event or Problem
PATIENT RECEIVED REVANESSE VERSA + (W/ LIDOCAINE) (LOT 241123) IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES VIA MICROCANNULA ON (B)(6) 2025. WAS FINE UP UNTIL EARLY (B)(6) 2025; SHE NOTICED SUDDEN ONSET OF PALPABLE NODULE DEVELOPMENT ON THE AREAS TREATED. THE NODULES ARE PALPABLE, NON-TENDER, AND NON-ERYTHEMATOUS. PATIENT WAS OFFERED TO RESOLVE PRODUCT BUT WANTED TO HOLD OFF SINCE SHE DOES LIKE THE RESULTS NOT JUST THE PALPABLE NODULES.
Remedial action
- Patient Monitoring