InjuryLMH
REVANESSE LIPS+ (WITH LIDOCAINE)
Received Jun 23, 2025 · Event occurred May 29, 2025
Report 3004423487-2025-00017 · MDR key 22309240
Device
Generic name
Implant, Dermal, For Aesthetic Use
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40149Lot number
24K093
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Female
- Rash
- Rash
Narrative
Description of Event or Problem
PATIENT WAS INJECTED 12 DAYS AGO WITH RADIESSE AND REVANESSE LIPS+ AND RHA. 2 AND REDENSITY. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. 7 DAYS POST INFECTION DEVELOPED A RASH, RASH IS MORE PROMINENT IN THE AREAS WHERE THE LIPS+ WAS INJECTED.
Remedial action
- Patient Monitoring