REVANESSE VERSA+ 1.2 ML

Description of Event or Problem

ON (B)(6) 2024 A PATIENT RECEIVED 0.25 CC OF REVANESSE VERSA+ UNDER EACH EYE, IN THE MID PUPILLARY LINE. THE PRODUCT WAS PLACED ON THE "ORBITAL RIM". BLT COMPOUNDED TOPICAL ANESTHETIC WAS APPLIED TO THE AREA PRIOR TO INJECTION. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME UNSPECIFIED LATER DATE THE PATIENT COMPLAINED OF SWELLING UNDER THE EYES. THERE WERE NO NODULES, ERYTHEMA OR INFLAMMATION. NO PHOTOS WERE PROVIDED. THE PRODUCT AND AREA WAS TREATED WITH HYLENEX AND RF MICRO NEEDLING. MY CLINICAL OPINION BASED ON THE LIMITED INFORMATION PROVIDED, IS THAT THIS CASE REPRESENTS SUBOPTIMAL PRODUCT SELECTION AND PLACEMENT. THERE IS NO HISTORY OF PRODUCT AES. THE PATIENT'S DISSATISFACTION WAS TREATED BY DISSOLVING THE PRODUCT. INTERNAL REPORT NUMBER: (B)(4).