REVANESSE LIPS+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE PATIENT, ON (B)(6), 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED IN THE LIPS AREA OF THE PATIENT. THE VOLUME INJECTED IS 0.7 ML. PATIENT IS (B)(6). FIRST DERMAL FILLER TREATMENT. ACCORDING TO THE INJECTOR, PATIENT HAD NO PRE-EXISTING RISK FACTORS. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. ELEVATED FITZPATRICK SCALE: FP-4 AS REPORTED BY INJECTOR, PATIENT WAS SEEN ON (B)(6) 2021 AND (B)(6) 2021 AND WAS REASSURED PATIENT WAS HEALING. NO ALLERGIC REACTION. MILD SWELLING AND BRUISING POST INJECTION. NOTHING UNUSUAL NOTED AS REPORTED BY INJECTOR. NO MEDICATIONS AFTER/BEFORE THE TREATMENT REPORTED. PATIENT DID NOT DISCLOSE VACCINATION STATUS FROM COVID-19. TOPICAL ANESTHETIC USED: BENZOCAINE/LIDOCAINE/TETRACAINE (20/10/10) POST INJECTION ICE PACK APPLIED IN OFFICE. NO MEDS GIVEN BY OFFICE OF THE CLINIC. AS REPORTED BY PATIENT, SHE HAS HAD A FILLER DISSOLVING PROCEDURE BY ANOTHER BOARD-CERTIFIED DERMATOLOGIST. MEDICATION IS NOT SPECIFIED. PATIENT MENTIONED TO POSSIBLE HAVE ANOTHER FILLER DISSOLVING PROCEDURE DUE TO CONTINUOUS FEELING OF LUMPS TWO WEEKS AFTER THE DATE OF INITIAL REPORT. AS REPORTED BY INJECTOR, INJECTOR DOES NOT BELIEVE THIS PATIENT HAD AN ADVERSE REACTION TO THE PRODUCT AT ALL. INJECTOR ATTACHED ALL INFORMATION REQUESTED AND ALL PRE AND POST PICTURES IN EMAILS THAT WERE INITIALLY SENT OUT BY QA DEPARTMENT. AS REPORTED BY INJECTOR, THE PATIENT WAS VERY ANXIOUS AND NERVOUS AND INJECTOR STATED TO THINK PATIENT'S LIPS WERE HEALING NORMALLY. THERE WAS NO ALLERGIC REACTION. PATIENT SAW HER SEVERAL TIMES POST INJECTION TO REASSURE HER ON (B)(6) 2021 AND (B)(6) 2021 AND THERE WAS NOTHING WRONG IN INJECTOR'S PROFESSIONAL OPINION WITH INJECTION TECHNIQUE OR PRODUCT.

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 ONE PREVIOUS CLINICAL COMPLAINT HAS 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 WAS PROVIDED TO THE CLINIC AND TO THE PATIENT ALONG WITH THE LETTER STATING APPROVED INDICATION FOR THE REVANESSE LIPS+ PRODUCT LINE: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE PHOTOS AND INFORMATION OUTLINED BELOW; THE PATIENT HAD FILLER INJECTED INTO HER LIP IN (B)(6) OF THIS YEAR. THERE IS NO HISTORY OF INFLAMMATION OR NODULES. PHOTOS PROVIDED BY THE CLINIC AND PATIENT DO NOT SHOW ANY SIGNS OF A PRODUCT AE. THE POST PHOTOS DO SHOW BOLUSES OF PRODUCT THAT HAVE BEEN INJECTED TOO SUPERFICIAL AND SO ARE VISIBLE THEY THE THIN EPITHELIUM OF THE LIP. THE PATIENT SUBSEQUENTLY SAW A DERMATOLOGIST WHO CORRECTLY DISSOLVED THE SUPERFICIALLY INJECTED PRODUCT. THIS CASE DOES NOT REPRESENT A PRODUCT AE BUT RATHER A SUBOPTIMAL SUPERFICIAL INJECTION. I HOPE THIS CLINICAL OPINION IS OF VALUE TO ALL PARTIES INVOLVED."