InjuryLMH
REVANESSE VERSA+ 1.2 ML
Received May 25, 2023 · Event occurred Feb 7, 2023
Report 3004423487-2023-00017 · MDR key 17007659
Device
Generic name
Revanesse Versa+
Model number
40083Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
27 YR · Female
- Nodule
- Swelling/ Edema
- Nodule
- Swelling/ Edema
Narrative
Description of Event or Problem
ON (B)(6) 2023, A PATIENT WAS INJECTED WITH 0.8 ML OF REVANESSE VERSA+ HA FILLER INTO THEIR LIPS. A TOPICAL ANESTHETIC WAS USED, OINTMENT LIDOCAINE 23%, TETRACAINE 7%, LIPS. PATIENT HAD A VIRAL INFECTION AND WAS IN BED FOR 2-3 DAYS. SHE NOTICED HER LIPS GOT SWOLLEN AND FORMED 2 LITTLE LUMPS. NO TREATMENT WAS GIVEN. SHE JUST MONITORED IT. IN A COUPLE OF DAYS WHEN SHE WAS FEELING BETTER, THE LIPS WERE NO LONGER SWOLLEN AND THE NODULES WENT AWAY. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION. INTERNAL REPORT NUMBER: (B)(4).