REVANESSE LIPS+(WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

AS PER INJECTION, A 53 YO FEMALE WAS INJECTED WITH 1.1 ML REVNASSE LIPS+ (WITH LIDOCAINE) INTO HER UPPER LIPS AND SMALL AMOUNT (0.1 ML) INTO LOWER LIP ON (B)(6) 2023. PRIOR TO THE INJECTION 5%TOPICAL LIDOCAINE WAS APPLIED TO THE LIPS. PROCEDURE WENT WELL, NO MAJOR SWELLING OR BRUISING. USED TENTING TECHNIQUE TO ENHANCE LIPS, SO SUPERFICIAL INJECTIONS. NOTHING ABNORMAL TO REPORT. 3 HOURS LATER, THE PATIENT INFORM THE INSPECTOR WITH SENDING PICTURES THAT SHOW SWELLING OF THE UPPER LIP AND SHE WAS HAVING AN ALLERGIC REACTION. PATIENT WAS TOLD TO TAKE BENADRYL AND THAT DOCTOR WOULD CALL PATIENT. DOCTOR TRIED THREE TIMES TO REACH PATIENT LATER THAT EVENING TO NO AVAIL. PATIENT WAS SEEN NEXT MORNING AND PRESCRIBED A MEDROL PACK. THE PATIENT REPORTED THAT THE LIPS HAD GONE BACK TO NORMAL SIZE. THE PATIENT RECENTLY HAD COVID AND WAS ALSO PUT ON PAXLOVID. THE BATCH RECORD, QC TEST REPORTS (13-MAR-2023), AND QC FINAL INSPECTION REVIEW CHECK LIST (23-MAR-2023) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER: 23B165 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. NO RECORD WAS FOUND IN THE CAPA-, DEVIATION-, NCR- AND OOS LOGS ASSOCIATED WITH THE LOT: 23B165. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "ON (B)(6) 2023, A PATIENT RECEIVED REVANESSE LIPS+ INJECTED INTO THEIR LIPS. PRIOR TO THE INJECTION 5%TOPICAL LIDOCAINE WAS APPLIED TO THE LIPS. THE MAJORITY OF THE PRODUCT WAS INJECTED INTO HE UPPER LIP. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THREE ( 3) HOURS LATER THE PATIENT SENT A PICTURE OF SWELLING OF THE UPPER LIP. ANTIHISTAMINES FOLLOWED BY MEDROL PACK WERE PRESCRIBED AND THE SWELLING RESOLVED WITHIN 24 HOURS. THE PATIENT RECENTLY HAD COVID AND WAS ALSO PUT ON PAXLOVID. MY CLINICAL OPINION IS THAT THIS ADVERSE EVENT IS A CASE OF COLLATERAL INFLAMMATORY REACTION TO FILLER POST COVID INFECTION. IT IS FELT TO BE CAUSED BY THE ELEVATED IMMUNE RESPONSE CAUSED BY THE COVID INFECTION. IT IS ALSO KNOWN THAT 5% OF PEOPLE GET A REBOUND COVID INFECTION 7-30 DAYS POST PAXLOVID. I HOPE THIS CLINICAL OPINION WILL BE OF VALUE TO ALL CONCERNED. " INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).

Additional Manufacturer Narrative

THE BATCH RECORD, QC TEST REPORTS (13-MAR-2023), AND QC FINAL INSPECTION REVIEW CHECK LIST (23-MAR-2023) WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER: 23B165 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY.