REVANESSE LIPS+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER WAS NOT PROVIDED IN ORDER TO CONFIRM IF IT RELEASED BY THE COMPANY. ALSO, AS LOT# WAS NOT AVAILABLE PROLLENIUM WERE NOT ABLE TO INVESTIGATE FOR PREVIOUS CLINICAL COMPLAINTS, BATCH RECORDS, QC TESTING REPORTS, EMPLOYEE'S TRAININGS, SPECIFICATIONS, AND IF THE PRODUCT WAS MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM'S MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WAS PROVIDED TO THE CLINIC AS BELOW: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BELOW BY INJECTOR; APPROXIMATELY 6-7 MONTHS AGO THE PATIENT HAD REVANESSE LIPS INJECTED INTO HER UPPER AND LOWER LIPS. THERE IS NO HISTORY OF TOTAL VOLUME OF PRODUCT USED OR THE EXACT LOCATIONS OF THE INJECTIONS (IE. VERMILLION VS BODY OF THE LIP). AN AFTER PHOTO WAS PROVIDED. UNFORTUNATELY THERE IS NO BEFORE PHOTO. THE PATIENT HAS HAD HA LIP FILLERS OVER THE PAST 12 YEARS. THERE IS NO HISTORY OF PROCEDURE COMPLICATIONS, INFLAMMATION, NODULES OR REACTIONS. SEVERAL MONTHS AFTER THE INJECTION THE PATIENT NOTICED ASYMPTOMATIC " WHITE SPOTS" UNDER THE THIN EPITHELIUM OF THE LIPS WHICH SHE THEN BROUGHT TO THE ATTENTION OF INJECTOR. INJECTOR MADE A CLINICAL DIAGNOSIS OF FORDYCE SPOTS ( VISIBLE SEBACEOUS GLANDS ) WHICH ARE PRESENT IN EVERYONES LIPS AND GET LARGER AND MORE NOTICEABLE WITH AGE. THE PHOTO PROVIDED CLEARLY SHOW FORDYCE SPOTS ON THE LOWER LIP. THE CENTRAL PORTION OF THE UPPER LIP SHOWS AN AREA OF EPITHELIAL LAXITY OR SUPERFICIAL PRODUCT HOWEVER THE PHOTO IS NOT DETAILED ENOUGH TO MAKE A CLINICAL ASSESSMENT. A BEFORE PHOTO AND A ZOOMED PHOTO OF THE OPEN UPPER LIP WOULD BE OF VALUE. MY CLINICAL ASSESSMENT IS THAT THESE ARE FORDYCE SPOTS WITH NO EVIDENCE OF A PRODUCT ADVERSE EVENT. IF THE CENTRAL UPPER LIP IS AN AREA OF PATIENT CONCERN INJECTOR CAN EASILY ADDRESS THAT IN HER CLINIC. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES CONCERNED."

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, 6 MONTHS PRIOR (~ (B)(6) 2021) TO REPORTING DATE, (B)(6) 2022, PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) IN HER UPPER AND LOWER LIPS. PATIENT IS FEMALE. ON (B)(6) 2022 PATIENT REPORTED TO INJECTOR REGARDING THE WHITE SPOTS ON HER UPPER AND LOWER LIPS AFTER 6 MONTHS FROM THE INJECTION DATE. INJECTOR OF THE CLINIC INFORMED THE PATIENT THAT THERE ARE NO CHANCE OF VASCULAR OCCLUSION AFTER SIX MONTHS WITHOUT NECROSIS. ACCORDING TO INJECTOR IT WAS REPORTED TO BE MOST LIKELY SEBACEOUS GLANDS, BUT PATIENT WANTED INJECTOR TO CONTACT THE MEDICAL DIRECTOR OF PROLLENIUM MEDICAL TECHNOLOGIES. PATIENT PREVIOUSLY HAVE HAD DERMAL FILLERS FOR LAST 12 YEARS WITHOUT ANY ISSUES AS REPORTED BY INJECTOR.