REVANESSE LIPS+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT IS IN THE PROCESS OF BEING 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 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 STATING APPROVED INDICATION FOR THE REVANESSE LIPS+ PRODUCT LINE ONCE REQUESTED INFORMATION IS RECEIVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE PATIENT, ON 01 DECEMBER, 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED IN THE LIPS AREA OF THE PATIENT (UPPER AND LOWER LIP). THE VOLUME INJECTED IS 1.2 ML. PATIENT IS FEMALE; AGE IS UNKNOWN. IT IS UNKNOWN IF THIS WAS A FIRST DERMAL FILLER TREATMENT. AS REPORTED BY INJECTOR, PATIENT HAS CALLED BACK ON (B)(6) 2021 QUESTIONING A BUM ON HER LIP. THE PATIENT HAS SENT THREE PHOTOS TO INJECTOR. THE PATIENT WAS WAITING FOR RESOLUTION AT THE TIME OF THE INITIAL REPORT. QA/RA DEPARTMENT HAS ATTEMPTED TO REACH OUT TO CLINIC MULTIPLE TIMES REQUESTING ADDITIONAL INFORMATION FOR INVESTIGATIONAL PURPOSES, HOWEVER, REQUESTED INFORMATION HAS NOT BEEN PROVIDED AS OF 20 JAN 2022. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, THE PATIENT WAS INJECTED ON (B)(6) 2021 WITH REVANESSE LIPS+, LOT NUMBER 21H137 INJECTED IN THE LIPS AREA OF THE PATIENT (UPPER AND LOWER LIP). THE PRODUCT WAS INJECTED IN ITS ENTIRETY (1.2ML). AS REPORTED BY INJECTOR, PATIENT HAS CALLED BACK ON (B)(6) 2021 QUESTIONING A BUM ON HER LIP. PATIENT IS FEMALE; AGE IS UNKNOWN. IT IS UNKNOWN IF THIS WAS A FIRST DERMAL FILLER TREATMENT. THE MANUFACTURER COULD NOT OBTAIN FURTHER INFORMATION FROM THE CLINIC DESPITE REPEATED ATTEMPTS. THE MANUFACTURER COULD NOT OBTAIN FURTHER INFORMATION FROM THE CLINIC DESPITE REPEATED ATTEMPTS. ON (B)(6) 2022, QA HAS FORWARDED A NOTIFICATION LETTER TO THE CLINIC TO CONVEY THE NECESSITY OF PROVIDING ADEQUATE INFORMATION TO ENABLE ADEQUATE INVESTIGATIONS. MANUFACTURER HAS DECIDED TO CLOSE THE CASE. MEDICAL DIRECTOR WAS PROVIDED WITH THE LIMITED INFORMATION RECEIVED ON (B)(6) 2022 AS THE MANUFACTURER INTENDS TO CLOSE THE CASE. HIS RESPONSE IS PROVIDED BELOW: THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BY THE CLINIC IN CASE (B)(4). ON (B)(6) A PATIENT OF UNKNOWN AGE RECEIVED 1.2CC OF REVANESSE LIPS + INTO THEIR LIPS. THE WAS NO PAST MEDICAL HISTORY PROVIDED. THERE WAS NO ADVERSE EVENTS AT THE TIME OF INJECTION. ON (B)(6) THE PATIENT CONTACTED THE CLINIC WITH A CONCERN OF A "LUMP" ON THE LOWER LIP. THE PATIENT WAS NOT SEEN BUT SENT THE INJECTOR 3 PHOTOS. THERE WAS NO PAIN, REDNESS, SWELLING OR INFLAMMATION. THE 3 PHOTOS ALL CLEARLY SHOW AN AREA OF SUPERFICIAL PRODUCT GIVING THE APPEARANCE OF A LUMP. THE PRODUCT CAN BE SEEN THROUGH THE EPITHELIUM. THERE IS NO REDNESS, SWELLING, INFLAMMATION OR NODULES. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS PRODUCT PLACED IN A SUB OPTIMAL LOCATION ( DEPTH). THIS CAN BE CORRECTED BY MASSAGING THE AREA OR DISSOLVING THE SUPERFICIAL PRODUCT. I HOPE THIS CLINICAL OPINION WILL BE OF VALUE TO ALL PARTIES INVOLVED. MANUFACTURER HAS DECIDED TO CLOSE THE CASE. INTERNAL CASE REPORT NUMBER: (B)(6) 2202