InjuryLMH
REVANESSE VERSA+ 1.2 ML
Received Jan 4, 2023 · Event occurred Dec 1, 2022
Report 3004423487-2022-00064 · MDR key 16099206
Device
Generic name
Revanesse Versa+
Manufacturer
Prollenium Medical Technologies IncProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Rash
- Rash
Narrative
Description of Event or Problem
ON (B)(6) 2022 A FEMALE PATIENT RECEIVED REVANESSE VERSA+ INTO HER NASOLABIAL FOLDS AND EXPERIENCED A RASH POST INJECTION. THE INJECTOR AND THE CLINIC HAS BEEN CONTACTED SEVERAL TIMES VIA THE EMAIL ADDRESS PROVIDED IN THE INITIAL COMMUNICATION FOR MORE INFORMATION REGARDING THE ADVERSE EVENT, HOWEVER NO RESPONSE HAS BEEN RECEIVED. THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES WILL CONTINUE THE INVESTIGATION. INTERNAL COMPLAINT NUMBER: (B)(4).