REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) IN THE MAYLAR, NLF'S, ZYGOMA AREAS OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 4.8 ML, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE, HISPANIC; DATE OF BIRTH AND AGE OF THE PATIENT IS UNSPECIFIED. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING SWELLING AND BULLAE. THE DERMAL FILLER IN THE UPPER FACE WAS LATER DISSOLVED WITH 4 BOTTLES OF HYLENEX. XANAX, ZOLOFT GIVEN TO THE PATIENT. AS REPORTED, THE PATIENT DOES NOT HAVE PRE-EXISTING RISK FACTORS. PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. ELEVATED FITZPATRICK SCALE OF 3 REPORTED. NO TOPICAL ANAESTHETIC USED DURING THE PROCEDURE. NO ALLERGIES TO DERMAL FILLERS REPORTED. PATIENT IS NOT A FIRST TIME DERMAL FILLER TREATMENT. THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED OF THIS ADVERSE EVENT. CURRENT STATUS OF THE PATIENT: MARKED IMPROVEMENT, STILL HAS SOME MILD EDEMA.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO OTHER CLINICAL COMPLAINTS WERE FOUND ASSOCIATED WITH THIS LOT NUMBER. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT TO BE PROVIDED TO THE CLINIC ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE VERSA+ PRODUCT: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION AND PHOTOS PROVIDED BELOW; ON (B)(6) 2022 A PATIENT WAS INJECTED WITH A TOTAL OF 4.8 MLS OF REVANESSE VERSA+. HALF ( 2.4 MLS) WAS INJECTED INTO THE UPPER 1/3 OF THE FACE, SPECIFICALLY THE MALAR AREAS CK1 AND CK3. THE PATIENT HAD SOME BRUISING AND SWELLING IN THE INFRAORBITAL AND LATERAL PERI-ORBITAL REGIONS, BASED ON THE PHOTOS PROVIDED. THE PRODUCT WAS DISSOLVED WITH HYLENEX WHICH IMPROVED THE SYMPTOMS. THE PHOTOS PROVIDED SHOW A POST INJECTION EXACERBATION OF THE PATIENTS FESTOONS. THIS IS OFTEN REFERRED TO AS MALAR MOUNDS OR EDEMA. FESTOONING IS A PREEXISTING CONDITION CAUSED BY GENETICS, AGE AND UV SKIN DAMAGES OF THE LOWER EYELIDS. IT APPEARS WORSE IN THE MORNING AND IMPROVES THROUGHOUT THE DAY. IT CAN BE EXACERBATED BY THE COMMON PRACTISE OF FORCED HYDRATION OR WATER/ FLUID INTAKE BEYOND NORMAL THIRST. UNFORTUNATELY THE HYDROPHILIC NATURE OF HA FILLERS CAN ALSO MAKE THE APPEARANCE OF THE FESTOONS MORE PRONOUNCED. THE TREATMENT OF THIS CONDITION IS TO REDUCE FLUID INTAKE AND DISSOLVE THE HA, AS WAS DONE IN THIS CASE. IT IS IMPORTANT TO REMEMBER THAT IT MAY TAKE 2-3 INJECTIONS OF HYLENEX TO RETURN THE AREA TO PRE-INJECTION BASELINE. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS AN EXACERBATION OF PREEXISTING FESTOONING. I TRUST THIS OPINION WILL BE OF VALUE TO ALL PARTIES CONCERNED."