REVNAESSE VERSA + (WITH LIDOCAINE) 1.0 ML

Additional Manufacturer Narrative

THE CLINIC HAS NOT PROVIDED ALL THE REQUESTED INFORMATION. HOWEVER THE COMPLAINT WAS ADEQUATELY INVESTIGATED. THE LOT NUMBER WAS VERIFIED AND HAS BEEN CONFIRMED TO BE RELEASED BY THE COMPANY. IT HAS BEEN CONFIRMED THAT NO PREVIOUS CLINICAL COMPLAINTS HAVE BEEN FOUND FOR THIS PARTICULAR LOT NUMBER IN QUESTION. THE BATCH RECORD, QC TEST REPORTS AND TRAINING OF THE STAFF WERE ANALYZED AND IT HAS BEEN DETERMINED THAT THE PRODUCT IS WITHIN REQUIRED SPECIFICATIONS, AND MANUFACTURED ACCORDINGLY TO THE APPROPRIATE PROCEDURES.

Description of Event or Problem

THE CLINIC HAS REPORTED THAT 1 ML OF VERSA WITH LIDOCAINE WAS INJECTED INTO THE LIPS OF THE PATIENT. THE PATIENT DEVELOPED WHITE PAPULES DURING THE INJECTION. THE NEXT DAY THE SWELLING WAS TREMENDOUS. THE PATIENT WAS TREATED WITH HYALURONIDASE A WEEK POST INJECTION. PATIENT REPORTS SHE STILL HAS WHITE PAPULES AND LUMPS. PATIENT WILL BE SEEN HERE FOR THE SECOND HYALURONIDASE SOON. MEDICAL DIRECTOR WAS CONTACTED AND HIS EVALUATION WAS THAT THIS CASE IN HIS CLINICAL OPINION IS NOT AN ADVERSE EVENT BUT SIMPLY AN UNDESIRABLE LOCATION OF PRODUCT IN THE PATIENTS LIP.