REVANESSE LIPS+ 1.2 ML

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 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 WAS OBTAINED BASED ON THE INFORMATION PROVIDED. "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED BELOW; ALTHOUGH THERE IS LIMITED HISTORY AND NO PHOTOS THE HISTORY PROVIDED CLEARLY DESCRIBES AN INADVERTENT INTRAVASCULAR INJECTION IN THE LOWER LIP, MOST LIKELY INTO THE INFERIOR LABIAL ARTERY. THE PATIENT WAS GIVEN ASA AND HYLENEX. THERE IS NO HISTORY OF PATIENT OUTCOME, HOWEVER TREATMENT WAS STARTED IMMEDIATELY, SO ONE HOPES AND ASSUMES NO NECROSIS OCCURRED. THE PATIENTS UPPER LIP WAS ALSO INJECTED WITH NO ISSUES OR ADVERSE EVENTS DOCUMENTED. I TRUST THIS OPINION IS OF VALUE TO ALL PARTIES INVOLVED."

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON (B)(6) 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED IN THE LIPS AREA OF THE PATIENT. TOP LIP WAS INJECTED WITH NO UNTOWARD EFFECT. INJECTOR INJECTED APPROXIMATELY 0.3 ML INTO RIGHT SIDE OF TOP LIP WITH NO COMPLICATIONS. THEN BEGAN INJECTING INTO LOWER PORTION OF RIGHT LIP AND IMMEDIATELY BEGAN TO SEE BLANCHING. AT THIS POINT INJECTOR STOPPED, ADMINISTERED TWO 81 MG ASPIRIN TABLETS AND THEN BEGAN INJECTING HYLENEX. PATIENT IS FEMALE, CAUCASIAN AND DATE OF BIRTH - (B)(6) 1985. PATIENT DENIES ANY SIGNIFICANT MEDICAL HISTORY. INJECTOR IS THE MEDICAL DIRECTOR OF THE CLINIC ((B)(6)). TOPICAL ANESTHETIC USED: BLT CREAM. PATIENT HAS HAD REVANESSE VERSA FILLER INJECTED INTO THE LIPS SEVERAL MONTHS PRIOR. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. NO ELEVATED FITZPATRICK REPORTED. THE CLINIC AND REPRESENTATIVE WERE REACHED OUT MULTIPLE AMOUNT OF TIMES FOR PATIENT PHOTOS, HOWEVER, NO REPLY AS OF 22 DEC 2021 HAS BEEN RECEIVED. QA DEPARTMENT HAS REACHED OUT TO THE INJECTOR AND CLINIC FOR PHOTOS MULTIPLE AMOUNT OF TIMES DURING FEW MONTHS. INJECTOR HAS INFORMED TO SEND THE PHOTOS, HOWEVER, AS OF 22 DEC 2021, NO PHOTOS HAS BEEN RECEIVED. DESPITE THIS, QA DEPARTMENT HAS REACHED OUT TO MEDICAL DIRECTOR OF THE PROLLENIUM MEDICAL TECHNOLOGIES IN ORDER TO FINALIZE THIS INVESTIGATION.

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 NO PREVIOUS CLINICAL COMPLAINTS HAVE 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. LETTER STATING THAT USE OF COMPOUNDED TOPICAL ANESTHETICS ON THE LIPS HAS BEEN IMPLICATED IN MULTIPLE ADVERSE EVENTS, INCLUDING THIS ONE, AND SHOULD BE AVOIDED WILL BE PROVIDED TO THE CLINIC. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ONCE FULL INFORMATION REQUESTED IS RECEIVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE CLINIC, ON (B)(6) 2021 - DATE OF TREATMENT WITH REVANESSE LIPS+ INJECTED IN THE LIPS AREA OF THE PATIENT. TOP LIP WAS INJECTED WITH NO UNTOWARD EFFECT. INJECTOR INJECTED APPROXIMATELY 0.3 ML INTO RIGHT SIDE OF TOP LIP WITH NO COMPLICATIONS. THEN BEGAN INJECTING INTO LOWER PORTION OF RIGHT LIP AND IMMEDIATELY BEGAN TO SEE BLANCHING. AT THIS POINT INJECTOR STOPPED, ADMINISTERED TWO 81 MG ASPIRIN TABLETS AND THEN BEGAN INJECTING HYLENEX. PATIENT IS FEMALE, CAUCASIAN (B)(6) AND DATE OF BIRTH - (B)(6). PATIENT DENIES ANY SIGNIFICANT MEDICAL HISTORY. INJECTOR IS THE MEDICAL DIRECTOR OF THE CLINIC ((B)(6)). TOPICAL ANESTHETIC USED: BLT CREAM. PATIENT HAS HAD REVANESSE VERSA FILLER INJECTED INTO THE LIPS SEVERAL MONTHS PRIOR. NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. NO ELEVATED FITZPATRICK REPORTED. THE CLINIC AND REPRESENTATIVE WERE REACHED OUT MULTIPLE AMOUNT OF TIMES FOR PATIENT PHOTOS, HOWEVER, NO REPLY AS OF 30 SEP 2021 HAS BEEN RECEIVED. QA DEPARTMENT WILL CONTINUE INVESTIGATION.