MalfunctionLMH
REVANESSE VERSA
Received Jan 11, 2019 · Event occurred Apr 1, 2018
Report 3004423487-2019-00001 · MDR key 8242079
Device
Generic name
Dermal Filler
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40081Lot number
17K006
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Pain
- Swelling
- Tingling
- Pain
- Swelling
- Tingling
Narrative
Description of Event or Problem
PATIENT WAS INJECTED WITH REVANESSE VERSA AND EXPERIENCED PAIN, TINGLING AND SWELLING IN BOTH THE UPPER AND LOWER LIP. THE DOCTOR INDICATED HE TREATED WITH VITRASE WHICH HAS BROUGHT DOWN THE SWELLING BUT EXPRESSED CONCERN OVER THE PAIN/TINGLING.