REVANESSE LIPS+ 1.2 ML

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 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 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.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, THE PATIENT WAS INJECTED WITH REVANESSE LIPS+ (WITH LIDOCAINE) IN THE LIPS AREA OF THE PATIENT ON (B)(6) 2022. AMOUNT OF PRODUCT INJECTED WAS 1.2 ML 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. DATE OF BIRTH: (B)(6). ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS EXPERIENCING SWELLING, REDNESS, NODULES. 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 29 APR 2022, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. ON 24 MAY 2022, AS A RESULT OF NO RESPONSE, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES CONTACTED CLINIC/INJECTOR AGAIN REQUESTING INFORMATION REGARDING THIS CLINICAL COMPLAINT. AS OF 24 MAY 2022, QA DEPARTMENT AT PROLLENIUM MEDICAL TECHNOLOGIES RECEIVED NO RESPONSE. THE QA DEPARTMENT WILL CONTINUE THE INVESTIGATION.