REVANESSE LIPS+(WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR, A PATIENT, A 21 YEARS OLD FEMALE, WAS INJECTED WITH 0.9 ML REVANESSE LIPS+ (WITH LIDOCAINE) IN LIPS ON (B)(6) 2022. PATIENT REPORTED NO ISSUES UNTIL 3/24/23 WITH SWOLLEN LIPS AND FLU LIKE SYMPTOMS. DOXYCYCLINE WAS PRESCRIBED, AND PATIENT SAW IMPROVEMENT. MEDROL PACK WAS PRESCRIBED, BUT PATIENT HAS NOT STARTED TREATMENT. WILL FOLLOW UP IN 14 DAYS, AND PATIENT WILL RETURN TO DISSOLVE. THE LOT NUMBER 22G196 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS (10-AUG-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (17-AUG-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 CLINIC HAS BEEN REQUESTED SEVERAL TIME (11-APR-2023, 18-APR-2023,24-APR-2023 AND 26-APR-2023) FOR THE MORE INFORMATION SUCH AS THE PATIENT'S INFORMATION (E.G. RACE, MEDICAL HISTORY, CURRENT STATUS), THE ADVERSE EVENT DETAILS AND IMAGES BEFORE AND AFTER THE INJECTION, BUT HAVE GOT NO RESPONSE FROM THE CLINIC.

Additional Manufacturer Narrative

THE LOT NUMBER 22G149 WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS (10-AUG-2022), AND QC FINAL INSPECTION REVIEW CHECK LIST (17-AUG-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.