REVANESSE LIPS+ 1.2 ML
Received May 15, 2023 · Event occurred Apr 14, 2023
Report 3004423487-2023-00013 · MDR key 16935527
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Obstruction/Occlusion
- Obstruction/Occlusion
Narrative
Description of Event or Problem
ON (B)(6) 2023, A PATIENT WAS INJECTED WITH REVANESSE LIPS+ HA FILLER INTO THEIR LIPS. THE INJECTOR DID NOT KNOW HOW MUCH PRODUCT WAS INJECTED. AT SOME POINT IN THE PROCEDURE THE INJECTOR NOTICED BLANCHING ABOVE THE RIGHT SIDE OF THE UPPER LIP. PHOTOS SHOW BLANCHING, MOTTLING AND CIRCUMFERENTIAL COMPENSATORY VASCULAR FLUSHING. THE INJECTOR INJECTED HYLENEX TO THE INVOLVED AREA TWICE. THE VASCULAR EVENT RESOLVED WITH NO SEQUELAE. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A CASE OF INADVERTENT INJECTION INTO A VESSEL CAUSING VASCULAR OCCLUSION WHICH WAS APPROPRIATELY MANAGED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION AND CONTACT THE INJECTOR, PATIENT AND CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. INTERNAL REPORT NUMBER: (B)(4).