REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLIANT WAS ADEQUATELY INVESTIGATED. 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 THE PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDINGLY TO THE APPROPRIATE PROCEDURES.

Description of Event or Problem

HE CLINIC REPORTS THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ WITH LIDOCAINE (LOT 20G008) TO THE NASOLABIAL FOLDS ON (B)(6) 2020 UTILIZING THE ENTIRE 1ML SYRINGE DURING INJECTION. THE PATIENT PRESENTED SEVERAL HOURS AFTER INJECTION WITH REDNESS AND BURNING AT THE SITE OF THE INJECTION THAT CONTINUED TO SPREAD DOWN HER FACE AND HER NECK. THE REDNESS WAS PRESENT ON BOTH SIDES OF HER FACE. PATIENT HAS NO ALLERGIES AND THE ONLY MEDICATION TAKEN IS A MULTI-VITAMIN. ON THE QUERY OF THE MEDICAL DIRECTOR, A CONFIRMATION WAS RECEIVED TO RULE OUT AN INTRA VASCULAR OCCLUSION. THE CLINIC RESPONDED SUSPECTING THIS IS A HISTAMINE REACTION. FOLLOWUP INDICATED THAT SHE WAS TREATED WITH STEROID PACK THAT CLEARED HER SKIN BUT STILL HAD A RED LINE FROM CHEEK DOWN HER NECK. A TOPICAL ANESTHETIC COMPOUND CREAM OF 20% BENZOCAINE, 6% LIDOCAINE AND 4% TETRACAINE WAS USED. MEDICAL DIRECTOR SUMMARISES THAT THE 20% BENZOCAINE ESTER ANESTHETIC WOULD BE THE MOST LIKELY TO TRIGGER THE PATIENTS HISTAMINIC ERYTHEMA. ANY RESIDUAL ERYTHEMA COULD BE CAUSED BY PIH.