InjuryLMH
REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML
Received Aug 6, 2024
Report 3004423487-2024-00017 · MDR key 19924214
Device
Generic name
Revanesse Versa+ (with Lidocaine) 1.2ml
Manufacturer
Prollenium Medical Technologies Inc.Model number
PN40083Lot number
21E014
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Female
- Nodule
- Nodule
Narrative
Description of Event or Problem
ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML,21E014 ON (B)(6) 2022 ON THE VERSA, 0.3ML OF PRODUCT WAS INJECTED. THE PATIENT REPORTS TO THE INJECTOR THAT SHE HAS DEVELOPED BUMPS ON HER LIPS A YEAR LATER. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED.
Remedial action
- Patient Monitoring