REVANESSE LIPS+ (WITH LIDOCAINE) 1.2 ML

Description of Event or Problem

ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS THAT PATIENT WAS INJECTED ON (B)(6) 2024 WITH REVANESSE LIPS+ WITH LIDOCAINE ON (B)(6) 2024 IN 0.5 ML CUPID'S BOW, RED VERMILLION TUBERCLE, UPPER AND LOWER LIPS. THE INJECTOR REPORTS THAT SHE OBSERVED ON (B)(6) 2024 THE PATIENT SHOWS TWO SMALL IMPROVING NODULES ARE PRESENT AT THE CORNERS OF THE MOUTH AND TWO ON THE UPPER LIP, CONTINUING TO DECREASE IN SIZE. THE NODULES AT THE MOUTH CORNERS ARE SEMI-HARD AND TENDER, WITH NO ERYTHEMA, SIGNS OF INFECTION, OR BIOFILM. NO FEVER IS PRESENT. MILD SWELLING IS NOTED, CONSISTENT WITH DELAYED-ONSET NODULES. THE PATIENT HAS COMPLETED THE SECOND COURSE OF PREDNISONE 60 MG TAPER AND A PROPHYLACTIC COURSE OF CIPROFLOXACIN 500 MG. OVER THE COURSE OF 9 VISITS FROM (B)(6) 2024 TO (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT THAT INCLUDED INTRALESIONAL HYLENEX AND KENALOG-40 INJECTIONS, ORAL STEROID COURSES, AND ULTRASOUND IMAGING. PROLLENIUM HAS REACHED OUT TO THE INJECTOR/CLINIC MULTIPLE TIME TO OBTAIN MORE INFORMATION TO CONDUCT A THROUGH INVESTIGATION HOWEVER NO RESPONSE WAS PROVIDED.