REVANESSE LIPS+ 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) IN THE LIPS AREA (UPPER AND LOWER LIP) OF THE PATIENT ON (B)(6) 2021. AMOUNT OF PRODUCT INJECTED WAS 1 CC IN THE LIPS AREA OF THE PATIENT, ACCORDING TO THE INITIAL REPORT. PATIENT IS FEMALE; AGE OF THE PATIENT IS (B)(6) AT THE MOMENT OF THE INITIAL REPORT. ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING SWELLING OF THE UPPER LIP THAT STARTED ON (B)(6) 2022. BUMP HAS DEVELOPED. PATIENT UNDERWENT DISSOLVING OF THE FILLER. PATIENT HAS STARTED A MEDROL DOSE PACK ON (B)(6) 2022. NO INFORMATION REGARDING TOPIC ANAESTHETIC HAS BEEN PROVIDED. NO INFORMATION REGARDING ALLERGIES HAS BEEN PROVIDED. NO INFORMATION REGARDING MEDICAL HISTORY AND PRESENCE OF RISK FACTORS HAVE BEEN PROVIDED. ON (B)(6)2022, SAME DAY OF NOTIFICATION, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 14 FEB 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 03 MAR 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 07 MAR 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON (B)(6) 2022, THE DOCTOR OF THE CLINIC INFORMED THE QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES THAT PATIENT HAD SOME MIGRATION OF HER FILLER RESULTING IN POOLING IN ONE AREA AND SOME DISSATISFACTION AND PAIN AND THAT THE PATIENT IS NO LONGER HAVING ANY ISSUES.

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 ONE OTHER CLINICAL COMPLAINT HAS BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION (B)(4). 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 ALONG WITH THE LETTER INDICATING APPROVED AREAS FOR INJECTION FOR REVANESSE LIPS+ PRODUCT WHEN REQUESTED INFORMATION FOR CONDUCTING INVESTIGATION IS PROVIDED.