REVANESSE VERSA+ 1.2 ML

Additional Manufacturer Narrative

THE CLINICAL COMPLAINT HAS BEEN ADEQUATELY INVESTIGATED. THE LOT NUMBER HAS BEEN VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINT HAS BEEN FOUND FOR THE PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS, AND TRAINING OF STAFF WERE ANALYSED AND IT HAS BEEN DETERMINED THAT PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDING TO APPROPRIATE PROCEDURES. QUALITY ASSURANCE AT PROLLENIUM MEDICAL TECHNOLOGIES PROVIDED THE CLINIC A LETTER STATING APPROVED INDICATION FOR THE REVANESSE VERSA+ PRODUCT LINE. THIS ADVERSE EVENT HAS BEEN RESOLVED.

Description of Event or Problem

BASED ON THE INFORMATION PROVIDED FROM THE PATIENT, ON (B)(6) 2021, DATE OF TREATMENT WITH REVANESSE VERSA+ INJECTED IN THE LIPS AREA OF THE PATIENT. THE VOLUME INJECTED IS 0.8 ML. PATIENT IS (B)(6). NO ALLERGIES TO DERMAL FILLER TREATMENTS REPORTED. AS REPORTED BY INJECTOR, PATIENT REPORTED NODULE ON INSIDE OF UPPER LIP. PATIENT REPORTED TO NOT BE PAINFUL. AS REPORTED, NODULE HAS APPEARED ONE WEEK POST INJECTIONS. QA DEPARTMENT HAS REACHED OUT TO CLINIC AND INJECTOR ON THE SAME DAY AS PER NOTIFICATION ON (B)(6) 2021 REQUESTING MORE INFORMATION. ON (B)(6) 2021, INJECTOR HAS RESPONDED TO THE MENTIONED EMAIL SENT BY QA DEPARTMENT. INJECTOR REPORTED THAT PATIENT FOLLOWED UP WITH THE INJECTOR AND THE ISSUE HAD ALMOST COMPLETELY RESOLVED ITSELF. A FEW DAYS LATER, PATIENT MESSAGED INJECTOR AND SAID IT WAS GONE COMPLETELY.