REVANESSE VERSA

Additional Manufacturer Narrative

THE BATCH RECORD AND TEST REPORT FOR LOT 17K090 WERE CHECKED AND VERIFIED. THE CERTIFICATE OF ANALYSIS, MANUFACTURING BATCH RECORD CHECKLIST, QUALITY CONTROL TEST REPORT AND PACKAGING DOCUMENTS WERE CHECKED AND DID NOT FIND ANY IRREGULARITIES IN THE RECORDS. ALL THE RECORDS WERE IN COMPLIANCE WITH STANDARD SPECIFICATIONS AND PRODUCT HAS PASSED. THERE IS NO DEVIATION OR NCR WAS ASSOCIATED WITH THIS LOT NUMBER.

Description of Event or Problem

THE PATIENT WAS INJECTED WITH REVANESSE VERSA (17K090) BY DR. (B)(6) ON (B)(6) 2019 INTO THE LIPS. THE PATIENT RECEIVED A TOPICAL APPLICATION OF LIDOCAINE 23% AND TETRACAINE 7% MIXED AT NOLA DISCOUNT. AFTER 12 HOURS, THE PATIENT REPORTED HAVING HIVES AND SWOLLEN LIPS. DR. TREECE TREATED PATIENT WITH A MEDROL (METHYLPREDNISOLONE) DOSE. ON (B)(6) 2019, THE PATIENT REPORTED THAT THE LIP AREA WAS IMPROVING. THE PATIENT HAD BEEN TREATED IN THE PAST YEAR WITH A REVANESSE VERSA INJECTION WITHOUT DEVELOPING ANY ADVERSE EVENT.