REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

ON (B)(6) 2023 A PATIENT RECEIVED 1.2 CC OF REVANAESSE VERSA+ INTO THEIR LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME LATER UNKNOWN DATE THE PATIENT FELT THERE WAS "SWELLING AND LUMPS" IN THEIR LIPS. THE PATIENT'S PHYSICIAN PUT THE PATIENT ON PREDNISONE WHICH RESOLVED THE SYMPTOMS. ON (B)(6) 2024 THE "SWELLING AND LUMPS" RETURNED. THE PATIENT WAS SEEN BY THE INJECTOR WHO DISSOLVED THE "AREAS OF CONCERN" WITH HYLENEX AND THE PATIENTS CONCERNS RESOLVED. DUE TO THE LACK OF MEDICAL INFORMATION IN THIS CASE, IT IS DIFFICULT TO PROVIDE AN ACCURATE CLINICAL OPINION. MY VIEW IS THAT THIS REPRESENTS A CASE OF SUBOPTIMAL LIP FILLING THAT RESULTED IN LUMPY DISTRIBUTION OF PRODUCT. THIS WAS EASILY RESOLVED WITH THE INJECTION OF HYLURONIDASE. INTERNAL REPORT NUMBER: (B)(4).