REVANESSE VERSA+ 1.2 ML

Additional Manufacturer Narrative

RESULTS OF INVESTIGATION: MANUFACTURER HAS COMPLETED ITS INTERNAL INVESTIGATIONS. THE LOT NUMBER 21F110 WAS CHECKED FOR THE SIMILAR OR ANY OTHER CLINICAL COMPLAINT IN THE CUSTOMER COMPLAINTS AND FEEDBACK LOG. NO OTHER CLINICAL COMPLAINT WAS FOUND ASSOCIATED WITH THIS LOT NUMBER. THE BATCH RECORD , QC TEST REPORTS, AND QC FINAL INSPECTION REVIEW CHECK LIST WERE ANALYSED AND IT HAS BEEN DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN FINAL RELEASE SPECIFICATIONS. THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES. THE LOT NUMBER 21F110 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAD BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. THE BATCH RECORDS AND REST OF THE REPORTS FOR THIS LOT HAD PASSED ALL TESTS AND A CHECK OF THE NCR LOG FOR THIS LOT NUMBER HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CHECK ON THE DEVIATION LOG HAD PRODUCED ZERO RESULTS FOR THIS LOT NUMBER AS WELL. THE CERTIFICATE OF ANALYSIS (COA) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. THE MANUFACTURER COULD NOT OBTAIN FURTHER INFORMATION FROM THE CLINIC DESPITE REPEATED ATTEMPTS. ON 18-OCT-2022, QA HAS FORWARDED A NOTIFICATION LETTER TO THE CLINIC TO CONVEY THE NECESSITY OF PROVIDING ADEQUATE INFORMATION TO ENABLE ADEQUATE INVESTIGATIONS. A MEDICAL ASSESSMENT COULD NOT BE MADE WITH THE LIMITED INFORMATION PROVIDED. MANUFACTURER HAS DECIDED TO CLOSE THE CASE.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, PATIENT WAS TREATED WITH REVANESSE VERSA+ 1.2 ML ON (B)(6) 2021. PATIENT CLAIMS OF SWELLING POST-TREATMENT AND HAS STAYED SWOLLEN WEEKS LATER. PATIENT HAS SWELLING UNDER THE EYES. PATIENT RECEIVED SECOND COVID-19 VACCINE ON (B)(6) 2021. PATIENT IS FEMALE AND WAS BORN ON (B)(6) 1979. ON (B)(6) 2021, QUALITY ASSURANCE DEPARTMENT HAS REACHED OUT TO THE CLINIC THAT PATIENT WAS TREATED AT, VERIFYING AND REQUESTING MORE INFORMATION. ON (B)(6) 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 18 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 22 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 22 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. AFTER MULTIPLE COMMUNICATIONS WITH CLINIC VIA EMAIL, CLINIC AND INJECTOR WERE NOT RESPONSIVE AND HAVE NOT PROVIDED ANY INFORMATION REGARDING THIS ADVERSE EVENT AS OF 22 NOV 2021.

Additional Manufacturer Narrative

AFTER MULTIPLE COMMUNICATIONS WITH CLINIC AND PATIENT VIA EMAIL/TELEPHONE, NO INFORMATION REGARDING THIS ADVERSE EVENT HAS BEEN RECEIVED AS OF 22 NOV 2021 BESIDES INITIAL NOTIFICATION INFORMATION. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION. PROLLENIUM MEDICAL TECHNOLOGIES' MEDICAL DIRECTOR'S RESPONSE TO THIS ADVERSE EVENT WILL BE PROVIDED TO THE CLINIC ONCE REQUESTED INFORMATION WILL BE RECEIVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED, PATIENT WAS TREATED WITH REVANESSE VERSA+ 1.2 ML ON 30 SEP 2021. PATIENT IS FEMALE AND WAS BORN ON (B)(6). . ON (B)(6) 2021, PATIENT WAS INJECTED IN THE LIPS AND LATERAL CHEEK AREA WITH REVANESSE VERSA+ 1.2 ML. PATIENT CLAIMS OF SWELLING POST-TREATMENT AND HAS STAYED SWOLLEN WEEKS LATER. PATIENT HAS SWELLING UNDER THE EYES. PATIENT RECEIVED SECOND COVID-19 VACCINE ON (B)(6) 2021. ON (B)(6) 2021, QUALITY ASSURANCE DEPARTMENT HAS REACHED OUT TO THE CLINIC THAT PATIENT WAS TREATED AT, VERIFYING AND REQUESTING MORE INFORMATION. ON 04 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 12 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 18 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. ON 22 NOV 2021, QA DEPARTMENT HAS REACHED OUT TO CLINIC AGAIN REGARDING REQUESTED INFORMATION. HOWEVER, CLINIC HAS NOT PROVIDED ANY RESPONSE. AFTER MULTIPLE COMMUNICATIONS WITH CLINIC VIA EMAIL, CLINIC AND INJECTOR WERE NOT RESPONSIVE AND HAVE NOT PROVIDED ANY INFORMATION REGARDING THIS ADVERSE EVENT AS OF 22 NOV 2021. QA DEPARTMENT WILL CONTINUE THE INVESTIGATION