REVANESSE VERSA+ (WITH LIDOCAINE) 1.0 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT WAS ADEQUATELY INVESTIGATED. THE LOT NUMBER (19G016) WAS CHECKED FOR THE SIMILAR OR ANY OTHER CLINICAL COMPLAINT IN THE CUSTOMER COMPLAINT LOG. NO 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. ITHE 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) YEARS WAS INJECTED ON (B)(6) 2020 WITH 0.5ML OF REVANESSE VERSA+ (WITH LIDOCAINE) PN40082,LOT # 19G016 ON THE LIPS. THE NURSE REPORTS THAT THE PATIENT BEGAN DEVELOPING SWELLING TO EYES IN AUGUST, THE SWELLING TO THE EYES SUBSIDED AND THEN THE LIPS BEGAN TO SWELL. THE SWELLING HAS REDUCED AFTER TREATMENT WITH PREDNISONE. SWELLING RESUMED AGAIN AFTER A FEW DAYS. CLIENT ALSO DEVELOPED HIVES ON VARIOUS PARTS OF THE BODY (ARMS,NECK ETC). THE MEDICAL DIRECTOR WAS CONTACTED AND HIS OPINION IS AS FOLLOWS- CLINICAL SYMPTOMS THIS PATIENT DESCRIBES ( HIVES, SWOLLEN EYES, SWOLLEN LIPS) AFTER 0.5CC OF HA WAS INJECTED INTO THE LIPS, BY DEFINITION IS A GENERALIZED ALLERGIC REACTION. SPECIFICALLY THIS WOULD REPRESENT ANGIOEDEMA WHICH IS USUALLY CAUSED BY DRUGS AND FOODS. IT IS IMPORTANT TO REMEMBER THAT COMPOUNDED TOPICAL ANESTHETICS ARE DRUGS AND DO GET INGESTED, VIA SALIVA, WHEN APPLIED TO THE LIPS. REACTIONS TO INJECTIONS OF HA, WOULD TYPICALLY BE LOCAL ALLERGIC REACTIONS SUCH AS IS SEEN WITH INSECT STINGS OR BITES. THEY WOULD ALSO BE SEEN WITHIN DAYS OF THE INJECTION. CLINICALLY HE DOES NOT FEEL THAT THIS CASE IS RELATED TO THE INJECTION OF HA AND THEREFORE HE WOULD NOT CLASSIFY THIS AS AN ADVERSE EVENT.