REVANESSE VERSA+

Additional Manufacturer Narrative

DEVICE HISTORY RECORD SUMMARY: THE RETROSPECTIVE REVIEW OF THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE ISSUES: THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS , AND MANUFACTURED ACCORDING TO THE APPROPRIATE PROCEDURES. THE BATCH RECORDS AND TEST REPORTS FROM THIS LOT HAS PASSED ALL TESTS AND A CHECK OF THE NCR AND DEVIATION LOG HAS PRODUCED ZERO RESULTS FOR THIS LOT NUMBER. THE CERTIFICATE OF ANALYSIS (C OF A) OF THIS LOT SHOWS THAT ALL TESTING PERFORMED ON THE PRODUCT HAS PASSED. THIS INJECTION WAS CONDUCTED PASS THE EXPIRATION DATE OF THE SYRINGE. THE MEDICAL DIRECTOR WAS CONTACTED. THIS ADVERSE EVENT IS UNDER CONSULTATION WITH MEDICAL DIRECTOR.

Description of Event or Problem

PATIENT HAD BEEN TREATED ON (B)(6) 2020 WITH 1.0ML VERSA+ INTO THE LIPS. 3 DAYS AFTER INJECTION SHE HAD ITCHY, BURNING, HOT WELTS AROUND HER MONTH AND CHIN. THE NURSE INJECTOR WOULD DESCRIBE IT AS ALLERGIC DERMATITIS. MEDICATIONS: BEFORE NP THYROID AFTER ANTIBIOTIC AND TOPICAL STEROID. PATIENT WAS GIVEN THE FOLLOWING: COLD COMPRESSES, HYALURONIDASE, ANTI-INFLAMMATORY (IE. ADVIL), PREDNISONE, ZITHROMAX, KEFLEX, OTHER ANTIBIOTICS.

Additional Manufacturer Narrative

1.CORRECTION TO SECTION E1 FROM INITIAL REPORT:- CHANGED THE MDR REPORTER COUNTRY FROM CANADA TO USA. 2. CORRECTION TO SECTION E2 FROM INITIAL REPORT:- CHANGED HEALTH PROFESSIONAL TO YES. 3.CORRECTION TO SECTION E3 FROM INITIAL REPORT:-CHANGED OCCUPATION TO PHYSICIAN ASSISTANT.