REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT WAS ADEQUATELY INVESTIGATED. THE LOT NUMBER (20G072) WAS CHECKED FOR THE SIMILAR OR ANY OTHER CLINICAL COMPLAINT IN THE CUSTOMER COMPLAINT LOG. ANY CLINICAL COMPLAINT WAS NOT FOUND IN THE LOG ASSOCIATED WITH THIS LOT NUMBER. THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. 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 NURSE INJECTOR REPORTED THAT THE PATIENT, FEMALE (B)(6) WAS INJECTED REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML ((B)(4)); LOT 20G072; EXPIRY DATE 30 DEC 2021. WITH ONE SYRINGE OF PRODUCT INTO THE LIPS ON THE (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2020 WITH A BUMP TO HER LIP WHICH SHE STATED SHE WAS NOT ABLE TO SMOOTH OUT. PATIENT WANTED MORE FILLER TO EVEN OUT THE LIPS. HOWEVER ON ASSESSMENT THE BUMP FEELS SMOOTH (NO LUMPS) AND ALMOST LOOKS TRANSLUCENT LIKE THE FILLER IS CLOSE TO THE SURFACE. IT APPEARS ONLY ON THE UPPER RIGHT SIDE. THE FILLER WAS NOT INJECTED SUPERFICIALLY AT ANY TIME. NO MEDICATIONS WERE GIVEN PRIOR TO OR AFTER TREATMENT. PATIENT HAD FILLER INJECTED IN THE LIP AREA BEFORE WITH JUVÉDERM ULTRA. THIS WAS A FIRST TIME USE FOR VERSA. THE MEDICAL DIRECTOR WAS CONTACTED AND THE SUMMARY OF HIS MEDICAL OPINION IS THAT BASED ON THE LACK OF NO CLINICAL SIGNS OR HISTORY OF NODULES, EDEMA, INFLAMMATION, ALLERGIC REACTIONS, VASCULAR EVENTS OR HERPETIC REACTION; THEREFORE IMPLIES THAT THERE ARE NO PRODUCT ADVERSE EVENTS. HE IS OF THE OPINION THAT THIS IS AN ISSUE OF SUPERFICIALLY PLACED PRODUCT WHICH USUALLY OCCURS FROM INJECTION TECHNIQUE. THE INFORMATION FROM THE MEDICAL DIRECTOR WAS COMMUNICATED TO THE NURSE INJECTOR. MANUFACTURER WILL FOLLOW UP WITH THE CLINIC TO REVIEW THE PATIENT STATUS.