REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

PATIENT RECEIVED THE INJECTION ON (B)(6) 2024. SUPERFICIAL MIGRATION OF FILLER OBSERVED 6+ MONTHS POST TREATMENT WITHIN WET TO DRY BORDER ON UPPER LIP. INTERNAL REPORT NUMBER: (B)(4).

Additional Manufacturer Narrative

MEDICAL OPINION FROM PROLLENIUM MEDICAL TECHNOLOGIES INC.: ON (B)(6) 2024 A RN INJECTOR INJECTED 1.2 CC OF REVANESSE VERSA + INTO A PATIENTS LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. NO TREATMENT PLAN WAS PROVIDED HOWEVER BASED ON THE POST PHOTO IT APPEARS THE TECHNIQUE OF VERTICAL LINEAR STRUT WAS USED. COMPOUNDED TOPICAL ANESTHETIC WITH LIDOCAINE 23%, TETRACAINE 7% IN "PLASTICIZED TOPICAL GEL", WAS APPLIED PRIOR TO INJECTION. "STRATAMED ADVANCED FILM-FORMING WOUND DRESSING" WAS APPLIED TO THE LIPS POST TREATMENT. NO BEFORE PHOTOS OR IMMEDIATE AFTER PHOTOS WERE PROVIDED OR TAKEN OF AREA IN QUESTION. SIX OR MORE+ MONTHS LATER THE PATIENT NOTICED A SMALL CENTRAL AREA OF FULLNESS IN THE INNER CENTRAL EVERTED LIP. THERE WAS NO PAIN, NO NODULES AND NO SIGNS OF INFLAMMATION. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS SUBOPTIMAL PRODUCT PLACEMENT. THIS IS VERY COMMON WITH VERTICAL STRUTS AS THESE ARE PERFORMED VERY SUPERFICIALLY TO AVOID THE SUPERIOR LABIAL ARTERY AND ARE DONE WITHOUT DIRECT VISUALIZATION. I SEE NO EVIDENCE IN THIS CASE OF A PRODUCT ADVERSE EVENT.