REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT WAS ADEQUATELY INVESTIGATED. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES.

Description of Event or Problem

THE TREATING PHYSICIAN REPORTED THAT THE PATIENT, FEMALE WAS INJECTED WITH REVANESSE VERSA+ WITH LIDOCAINE,LOT # 201075 1.1ML INJECTED INTO THE LIPS ON (B)(6) 2020. PATIENT WAS NUMBED ON LIPS FOR HALF HOUR WITH LIDOCAINE/TETRACAINE CREAM (CLINIC'S USUAL NUMBING TOPICAL FOR FILLERS). PATIENT RETURNED AT 3 WEEKS, WITH PALPABLE BUMP ON LOWER LEFT LIP. BUMP DID NOT CAUSE PAIN, NO SIGNS OF INFLAMMATION WHERE TO BE OBSERVED. PHYSICAIN REPORTED THAT IF DID NOT APPEAR AS DELAY ONSET NODULES. PATIENT REPORTED TO PHYSICIAN THAT SHE NOTICED IT AFTER LIP SWELLING HAS GONE AWAY IN THE FIRST 2 WEEKS.NO MEDICATION WAS GIVEN PRE-TREATMENT AND PATIENT WAS NOT ON ANY MEDICATION. NO MEDICATION AFTER TREATMENT, APART FROM A COURSE OF CLINDAMYCIN 300MG FOR 10 DAYS AFTER LEAVING CLINIC. THE MEDICAL DIRECTOR WAS CONTACTED AND HIS EVALUATION IS AS FOLLOWS. THE CLINICAL HISTORY IS CLEARLY OUTLINED IN THE AE REPORT, OF NOTE IS THE LACK OF PAIN, INFLAMMATION OR NODULES. THE "BUMP" IN THE PHOTO APPEARS TO BE A SLIGHT ASYMMETRY IN PRODUCT DISTRIBUTION WHICH IS VERY COMMONLY SEEN POST INJECTION DUE TO EITHER PATIENT MANIPULATION (SQUEEZING AND MASSAGING ESPECIALLY IF THEY FEEL THE AREA IS SWOLLEN) OR DURING INJECTION OF THE SECOND SIDE WHERE THE INJECTOR INADVERTENTLY IS CORRECTING FOR SWELLING SEEN ON THE FIRST SIDE INJECTED. I DO NOT FEEL THAT CLINICALLY THERE IS A FILLER AE OR COMPLICATION.