REVANESSE VERSA+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. 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 HAS BEEN PROVIDED TO THE CLINIC: "THE FOLLOWING CLINICAL OPINION IS BASED ON THE INFORMATION PROVIDED IN THE AE REPORT OUTLINED BELOW; ON (B)(6) 2021 THE PATIENT RECEIVED ~ 0.2 MLS OF REVANESSE VERSA+ HA PRODUCT INTO "SEVERAL" AREAS OF THE FACE. THE PATIENTS HISTORY REVEALS FOUR RISK FACTORS. A HISTORY OF MEDICATION ALLERGIES, A HISTORY OF FACTOR 5 LEIDEN DEFICIENCY, A HISTORY OF CHRONIC SINUS INFECTIONS AND A HISTORY OF PRIOR VOLUMA HA FILLER. THE LOCATION OF THE VOLUMA FILLER WAS NOT SHARED HOWEVER SINCE THE VERSA WAS PLACED IN SEVERAL COMMON FILLER LOCATIONS IT CAN LOGICALLY BE ASSUMED THAT THERE WAS OVERLAP IN THESE TWO PRODUCTS. ON (B)(6) 2021 THE PATIENT REPORTED TENDERNESS IN 5 AREAS OF PRIOR INJECTIONS. THE PHOTOS PROVIDED DO NOT SHOW SWELLING, LUMPS OR ERYTHEMA. THE HISTORY DOES NOT MENTION IF SHE HAD A FLARE UP OF HER CHRONIC SINUSITIS OR OTHER INFECTION WHICH IS A WELL DOCUMENTED CAUSE OF SWELLING OF HA FILLER ( VOLUMA AND VERSA). THIS HAS ALSO BEEN SEEN POST MRNA VACCINES. THIS SWELLING RESOLVES WITH THE RESOLUTION OF THE INFECTION. THE PATIENT WAS TREATED WITH MEDROL PACK, DOXICYCLINE AND RELATIVELY SMALL DOSES OF HYLENEX. ACCORDING TO THE SECONDARY HISTORY REQUESTED THE PATIENTS SYMPTOMS AND CONCERNS COMPLETELY RESOLVED. BASED ON THE HISTORY AND PHOTOS PROVIDED MY CLINICAL OPINION ON THIS CASE IS THAT IT PROBABLY REPRESENTS A WELL DESCRIBED PERI-FILLER INFLAMMATION SECONDARY TO A CO EXISTING INFECTION. IT IS EXCELLENT THAT THE PATIENTS CONCERNS HAVE COMPLETELY RESOLVED. THE PATIENTS HISTORY OF CHRONIC SINUS INFECTIONS WOULD REPRESENT A RELATIVE CONTRAINDICATION TO HAVING HA FILLER INJECTIONS. I TRUST THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES INVOLVED." AT THE MOMENT OF THE INITIAL REPORT, IT WAS DECIDED TO PUT THE ACCOUNT OF CLINIC ON HOLD AND PROHIBIT FUTURE ORDERS FROM PROLLENIUM MEDICAL TECHNOLOGIES UNTIL THIS ACTIVE ADVERSE EVENT IS RESOLVED. ONCE THE RESPONSE WAS RECEIVED ON (B)(6) 2021, CLINIC WAS ALLOWED FOR FURTHER REVANESSE PRODUCTS PURCHASES.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON 26 FEBRUARY,(B)(6) PATIENT WAS INJECTED WITH 1 ML FULL FACE. APPROXIMATELY 0.2ML TO SEVERAL AREAS INCLUDING UPPER LIPS, MARIONETTES, LATERAL CHEEKS AND TEAR TROUGHS. AFTER, THE CLINIC AND REPRESENTATIVE WERE REACHED OUT MULTIPLE AMOUNT OF TIMES, QA DEPARTMENT HAS RECEIVED RESPONSE FROM THE CLINIC. BELOW IS THE TIMELINE OF ATTEMPTS TO CONTACT THE CLINIC BEFORE FIRST AE REPORT SUBMISSION TO US FDA. PATIENT IS 46 YEAR OLD, FEMALE, CAUCASIAN. THE DATE OF ADVERSE REACTION IS (B)(6) 2021. THE PATIENT HAD 5 SEPARATE "NODULES." BILATERAL CHEEKS (2). BILATERAL MARIONETTES (2). ABOVE LEFT UPPER LIP (1). THE PATIENT COMPLAINED OF TENDERNESS UPON PALPATION. SLIGHT ERYTHEMA NOTED. AFEBRILE. RESOLVED WITH HYLENEX TO EACH AREA OVER 2 VISITS IN OFFICE. TOTAL HYLENEX USED 15-20 UNITS TO EACH "NODULE." PATIENT DENIES ANY MEDICATION USE PRIOR TO TREATMENT. POST (B)(6) 2021, MEDROL DOSE PACK & DOXYCYCLINE PRESCRIBED. PATIENT WENT TO URGENT CARE DUE TO TENDERNESS IN AREA (B)(6) 2021 AND RECEIVED ADDITIONAL MEDROL DOSE PACK. PATIENT WAS GIVEN DOXYCYCLINE, STEROID USE AND HYLENEX. PATIENT HAS HAD BOTOX IN PAST, VOLUMA PDO THREADS. TOPICAL ANESTHETIC USED: LIDO AND PRIMO SIN 5% EACH CREAM. PATIENT BACKGROUND INFORMATION REGARDING ALLERGIES: BACTRIM. FACTOR 5 DISEASE. HISTORY CHRONIC SINUSITIS. AS REPORTED BY INJECTOR, PATIENT DOES NOT HAVE PRE-EXISTING RISK FACTORS. PATIENT HAS HAD DERMAL FILLERS BEFORE. AS PER INJECTOR, NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. AS OF (B)(6) 2021, ADVERSE EVENT HAS BEEN RESOLVED. AT THE MOMENT OF THE INITIAL REPORT, IT WAS DECIDED TO PUT THE ACCOUNT OF CLINIC ON HOLD AND PROHIBIT FUTURE ORDERS FROM PROLLENIUM MEDICAL TECHNOLOGIES UNTIL THIS ACTIVE ADVERSE EVENT IS RESOLVED. ONCE THE RESPONSE WAS RECEIVED ON (B)(6) 2021, CLINIC WAS ALLOWED FOR FURTHER REVANESSE PRODUCTS PURCHASES.

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. 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 WILL BE PROVIDED TO THE CLINIC ONCE MORE INFORMATION IS PROVIDED: AT THE MOMENT OF THIS REPORT, IT WAS DECIDED TO PUT THE ACCOUNT OF CLINIC ON HOLD AND PROHIBIT FUTURE ORDERS FROM PROLLENIUM MEDICAL TECHNOLOGIES UNTIL THIS ACTIVE ADVERSE EVENT IS RESOLVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON (B)(6) 2021 - DATE OF TREATMENT WITH REVANESSE VERSA+ 1.2 ML INJECTED IN THE "VARIOUS AREAS" OF THE PATIENT. THE CLINIC AND REPRESENTATIVE WERE REACHED OUT MULTIPLE AMOUNT OF TIMES. ON (B)(6) 2021, SHORTLY AFTER REPORTING ADVERSE EVENT, QA DEPARTMENT HAS REACHED OUT CLINIC REQUESTING REQUIRED INFORMATION REGARDING EVENT. CLINIC WAS ALSO REACHED VIA TELEPHONE REQUESTING INFORMATION ABOUT THIS AE. CLINIC HAS INFORMED THAT THEY WILL PROVIDE MORE INFORMATION SHORTLY. ON (B)(6) 2021, QA DEPARTMENT TRIED TO FOLLOW UP WITH THE CLINIC REGARDING THIS AE, HOWEVER, NO RESPONSE HAVE BEEN RECEIVED. ON (B)(6) 2021, QA DEPARTMENT TRIED TO FOLLOW UP WITH THE CLINIC AGAIN VIA EMAIL HOWEVER, NO RESPONSE HAVE BEEN RECEIVED. ON (B)(6) 2021, QA DEPARTMENT HAS EMAILED SALES REPRESENTATIVE REGARDING THE FOLLOW-UP AND TO INQUIRE INFORMATION DIRECTLY FROM CLINIC AND WAS INFORMED THAT INJECTOR WILL PROVIDE MORE INFORMATION LATER. ON (B)(6) 2021, QA DEPARTMENT TRIED TO FOLLOW UP AGAIN VIA EMAIL HOWEVER, NO RESPONSE HAVE BEEN RECEIVED. NO REPLY HAS BEEN RECEIVED AS OF (B)(6) 2021. QA DEPARTMENT WILL CONTINUE INVESTIGATION. AT THE MOMENT OF THIS REPORT, IT WAS DECIDED TO PUT THE ACCOUNT OF CLINIC ON HOLD AND PROHIBIT FUTURE ORDERS FROM PROLLENIUM MEDICAL TECHNOLOGIES UNTIL THIS ACTIVE ADVERSE EVENT IS RESOLVED. NOTE: PROVIDED DESCRIPTION OF EVENT WERE PARTIALLY REPORTED BASED ON THE PHONE CALL WITH INJECTOR AND QA DEPARTMENT.