REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

THE CLINIC'S ACCOUNT WAS SENT ON 26-APR-2024: "INJECTED .8 IN LIPS, .4 IN CHIN, RADIESSE IN JAW LINE AND CHEEKS. INJECTED HER ON (B)(6). EVERYTHING WAS FINE UNTIL SHE GOT ON THE CRUISE ON THURS (B)(6) AND ON SUNDAY (B)(6) SHE REACHED OUT TO HER INJECTOR AND HER LIPS WERE REALLY SWOLLEN, PAINFUL AND FELT LIKE THERE IS LITTLE BB'S IN THEM. INJECTOR PRESCRIBED A STEROID PACK. TOOK FIRST DOSE YESTERDAY AND SWELLING IS DOWN TODAY BUT STILL BUMPS." HERE'S THE CLINICAL OPINION BY (B)(6) MEDICAL DIRECTOR", ON 31-MAY-2024: "THE FOLLOWING IS A CLINICAL RESPONSE BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2024 A PATIENT RECEIVED REVANESSE LIPS+ INTO THEIR LIPS AND CHIN. PRIOR TO INJECTION HIBICLENS, ALCOHOL, LIDOCAINE, TETRACAINE AND PHENLYEPHRINE WERE ALL APPLIED TO THE LIPS. RADIESSE WAS ALSO INJECTED INTO THE PATIENTS' CHEEKS AND JAW LINE. THERE WERE ADVERSE EVENTS OR CLINICAL CONCERNS AT THE TIME OF INJECTION. THE PATIENT WENT ON A CRUISE ON (B)(6) 2024 AND ON (B)(6) 2024, AFTER BEING IN THE SUN FOR THREE DAYS, REPORTED TO THEIR INJECTOR THAT THEIR LIPS WERE SWOLLEN AND THEY COULD FEELS TINY BUMPS. THE CHIN, CHEEKS AND JAWLINE WERE NOT SWOLLEN. IT WAS LATER DIAGNOSED THAT THE PATIENT HAD A POLYMORPHIC LIGHT ERUPTION REACTION TO THE SUN. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A REACTION TO INTENSE SUNLIGHT AND NOT AN ADVERSE EVENT TO HA FILLERS."