REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

ADVERSE EVENT INFORMATION: BASED ON THE INITIAL INFORMATION PROVIDED BY THE CLINIC, THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2 ML PN40083, LOT NUMBER 22L122 ON (B)(6) 2023 WITH 1.0ML OF VERSA ON THE LIPS. THE PATIENT STARTED TO EXPERIENCE UNILATERAL LIP SWELLING, 15 DAYS POST INJECTION. PRIOR TO TREATMENT BLT CREAM WAS USED. THE CLINIC INFORMED THE MANUFACTURER, THAT THE PATIENT WAS GIVEN DOXYCYCLENE 100MG BID FOR A WEEK AND THE SWELLING HAD NOT RESOLVED, SO THE PATIENT WAS BROUGHT BACK TO THE CLINIC WAS GIVEN A VIAL OF HYLENEX TO DISSOLVE THE FILLER. FOLLOW UP COMMUNICATIONS WITH CLINIC: FOLLOWING RECEIPT OF INITIAL REPORT, MANUFACTURER HAS REACHED OUT TO THE CLINIC FOR ADDITION INFORMATION PERTAINING TO THE REPORTED ADVERSE INCIDENT. THIS INFORMATION IS REQUIRED FOR PROLLENIUM'S MEDICAL DIRECTOR TO MAKE A SUITABLE MEDICAL ASSESSMENT OF THE CASE PRESENTED.