UNKNOWN

Additional Manufacturer Narrative

THE REQUIRED INFORMATION (E.G. ASSOCIATED WITH THE PRODUCT, THE PATIENT, IMAGES OF ADVERSE EVENT, INJECTION PLAN) HAS NOT BEEN PROVIDED BY THE CLINIC. THEREFORE, PROLLENIUM INTERNAL INVESTIGATION COULD NOT BEEN COMPLETED. THE PROLLENIUM MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED ADVERSE EVENT WAS OBTAINED WHICH IS AS FOLLOWS: "THIS IS NOT ENOUGH INFORMATION TO GIVE A MEDICAL OPINION ON THE ADVERSE EVENT AS THE TREATING DOCTOR IS NOT REPORTING IT AS AN AE. OUR US DIRECTOR OF MEDICAL AFFAIRS SHOULD REACH OUT TO THE DOCTOR AS THIS APPEARS TO BE WHAT THE DOCTOR WANTS IS A CALL FROM SAME".

Description of Event or Problem

BASED ON THE INFORMATION/REPORT PROVIDED BY THE CLINIC (THE INJECTOR: CLINIC'S MEDICAL DIRECTOR), ON (B)(6) 2022, A PATIENT WAS INJECTED WITH POLLENIUM PRODUCTS (PRODUCT TYPE, LOT# AND INJECTION VOLUME WERE NOT DISCLOSED) IN LIPS AND UNDER EYES. ON (B)(6) 2023, THE PATIENT COMPLAINED OF ITCHING, SWELLING FROM INJECTION OF VERSA IN THOSE AREA (LIPS; UNDER EYES). THE CLINIC'S MEDICAL DIRECTOR HAS REQUESTED SOMEONE FROM PROLLENIUM MEDICAL AFFAIR TO CONTACT HER. PROLLENIUM CONTACTED THE CLINIC MULTIPLE TIMES ((B)(6) 2023,(B)(6) 2023,(B)(6) 2023, (B)(6) 2023,(B)(6) 2023) BUT HAS RECEIVED NO RESPONSES FROM THE CLINIC . ALSO, THE PROLLENIUM DIRECTOR OF MEDICAL AFFAIRS IN THE US, HAS CONTACTED THE CLINIC AND HAS RECEIVED NO RESPONSE FROM THE CLINIC. SINCE THE REQUIRED INFORMATION (THE INFORMATION ASSOCIATED WITH THE PRODUCT, THE PATIENT, IMAGES OF ADVERSE EVENT, INJECTION PLAN) HAS NOT BEEN PROVIDED, PROLLENIUM COULD NOT COMPLETE INTERNAL INVESTIGATION (E.G. REVIEW THE BATCH RECORDS, QC TESTING RECORDS, EMPLOYEE TRAINING RECORDS, DEVIATION LOG). HOWEVER, AS PART OF PROLLENIUM INTERNAL INVESTIGATION, THE LIMITED INFORMATION WAS SENT TO THE PROLLENIUM MEDICAL DIRECTOR IN ORDER TO GET HIS MEDICAL OPINION ABOUT THIS CASE. THE PROLLENIUM MEDICAL DIRECTOR'S OPINION IS AS FOLLOWS: "THIS IS NOT ENOUGH INFORMATION TO GIVE A MEDICAL OPINION ON THE ADVERSE EVENT AS THE TREATING DOCTOR IS NOT REPORTING IT AS AN AE. OUR US DIRECTOR OF MEDICAL AFFAIRS SHOULD REACH OUT TO THE DOCTOR AS THIS APPEARS TO BE WHAT THE DOCTOR WANTS IS A CALL FROM SAME."