REVANESSE VERSA+(WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR, [ (B)(6), NP] A 61 YO FEMALE, WAS INJECTED WITH 1.2 ML REVANESSE VERSA+ (WITH LIDOCAINE) IN LIPS ON (B)(6) 2022. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THERE WAS NO REPORTED PAST MEDICAL HISTORY. IN (B)(6) 2023, THE PATIENT FELT SEVERAL SMALL LUMPS (ABOUT 10) IN HER LIPS WITH NO PAIN OF INFLAMMATION. SHE WAS SEEN BY HER PCP AND A DERMATOLOGIST BEFORE SHE CONTACTED THE INJECTOR. THE PATIENT WAS PUT ON AN "ANTIBIOTIC" (ABX) AND REPORTED A NOTICEABLE (40%) IMPROVEMENT. THE PATIENT DECLINED AN OFFER TO DISSOLVE THE PRODUCT. THE BATCH RECORD, QC TEST REPORTS (29-JUN-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (08-JUL-2022) WERE ANALYZED 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 22F183 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2022 A PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA +, INTO HER LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THERE WAS NO REPORTED PAST MEDICAL HISTORY. IN (B)(6) 2023, THE PATIENT FELT THEY HAD SEVERAL SMALL LUMPS IN THEIR LIPS. SHE WAS SEEN BY HER PCP AND A DERMATOLOGIST BEFORE SHE CONTACTED THE INJECTOR. NO COLLATERAL MEDICAL HISTORY SUCH AS VACCINES OR INFECTIONS WAS PROVIDED. THE INJECTOR FELT THERE WAS NO ERYTHEMA OR INFLAMMATION. THE PATIENT WAS PUT ON AN "ANTIBIOTIC" AND REPORTED A NOTICEABLE IMPROVEMENT. THE PATIENT DECLINED AN OFFER TO DISSOLVE THE PRODUCT. MY CLINICAL OPINION IS THAT THIS MAY REPRESENT A CASE OF DELAYED NODULES SECONDARY TO A COEXISTING INFECTIOUS CONDITION. THESE ADVERSE EVENTS USUALLY RESOLVE COMPLETELY WITH TIME AND TREATMENT. " INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).

Additional Manufacturer Narrative

HE BATCH RECORD, QC TEST REPORTS (29-JUN-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (08-JUL-2022) WERE ANALYZED 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 22F183 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE INFORMATION PROVIDED BY THE CLINIC HAS BEEN SUBMITTED TO THE PROLLENIUM MEDICAL DIRECTOR FOR REVIEW. THE MEDICAL DIRECTOR'S OPINION ABOUT THE REPORTED AE IS AS FOLLOWS: "THE FOLLOWING IS A CLINICAL OPINION BASED ON THE INFORMATION PROVIDED IN CASE (B)(4). ON (B)(6) 2022 A PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA +, INTO HER LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THERE WAS NO REPORTED PAST MEDICAL HISTORY. IN (B)(6) 2023, THE PATIENT FELT THEY HAD SEVERAL SMALL LUMPS IN THEIR LIPS. SHE WAS SEEN BY HER PCP AND A DERMATOLOGIST BEFORE SHE CONTACTED THE INJECTOR. NO COLLATERAL MEDICAL HISTORY SUCH AS VACCINES OR INFECTIONS WAS PROVIDED. THE INJECTOR FELT THERE WAS NO ERYTHEMA OR INFLAMMATION. THE PATIENT WAS PUT ON AN "ANTIBIOTIC" AND REPORTED A NOTICEABLE IMPROVEMENT. THE PATIENT DECLINED AN OFFER TO DISSOLVE THE PRODUCT. MY CLINICAL OPINION IS THAT THIS MAY REPRESENT A CASE OF DELAYED NODULES SECONDARY TO A COEXISTING INFECTIOUS CONDITION. THESE ADVERSE EVENTS USUALLY RESOLVE COMPLETELY WITH TIME AND TREATMENT. " INTERNAL PROLLENIUM COMPLAINT NUMBER: (B)(4).