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 UNDER EYES AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 1.2 CC, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE, CAUCASIAN; AGE OF THE PATIENT IS 41 YEARS OLD. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING SWELLING AND SHINGLES IN THE AREA TREATED WITH THE FILLER. PATIENT WAS GIVEN PREDNISONE, STEROIDS AND ANTI-VIRAL POST INJECTION. NO ELEVATED FITZPATRICK SCALE REPORTED. 1% XYLOCAINE PLAIN 0.2CC WAS USED AS TOPICAL ANAESTHETIC DURING THE PROCEDURE. NO ALLERGIES TO DERMAL FILLERS REPORTED. PATIENT IS A FIRST TIME DERMAL FILLER TREATMENT. PATIENT DOES NOT HAVE THE REPORTED PRE-EXISTING RISK FACTORS. CURRENT STATUS OF THE PATIENT: SHINGLES IMPROVED; STILL SWOLLEN THE MEDICAL DIRECTOR OF THE CLINIC HAS BEEN INFORMED OF THIS ADVERSE EVENT.

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 BY THE CLINIC. ON (B)(6) 2022 A 41 Y.O. A FEMALE PATIENT RECEIVED 1.2 CC OF VERSA+ HA FILLER IN HER "UNDER EYE" REGION. EXACT LOCATION OF THE PRODUCT PLACEMENT WAS NOT PROVIDED. THERE WERE NO ISSUES OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME TIME IN THE FOLLOWING 6 WEEKS (DATE NOT PROVIDED) THE PATIENT WAS DIAGNOSED WITH SHINGLES ON HER LEFT V2 MAXILLARY BRANCH DERMATOME. SHINGLES IS A REACTIVATION OF THE VARICELLA VIRUS WHICH REMAINS DORMANT IN THE NERVOUS SYSTEM. THE PHOTOS SHOW VESICLES IN 2 AREAS ON THE LATERAL NOSE AND ONE AREA ON THE LEFT CHEEK. THESE VESICLES WERE IN AREAS THAT NO TRAINED INJECTOR WOULD INJECT DUE TO THE VASCULAR RISK. THE PATIENT WAS TREATED WITH ANTIVIRALS AND PREDNISONE. THE AFTER PHOTOS SHOW THE RASH RESOLVED WHICH IS THE NATURAL COURSE. MY CLINICAL OPINION IS THAT THE PATIENT DEVELOPED SHINGLES UNRELATED TO THE ADMINISTRATION OF HA FILLER. I DO NOT VIEW THIS CASE AS A FILLER ADVERSE EVENT. I TRUST THIS CLINICAL OPINION WILL BE OF VALUE TO ALL PARTIES INVOLVED."