Description of Event or Problem · 0
THE PATIENT (INITIALS (B)(6)) WAS REFERRED TO MY OFFICE FOR MANAGEMENT OF THE FACIAL ABSCESS. SHE DEVELOPED BILATERAL FACIAL ABSCESSES IN THE NASOLABIAL FOLDS FOLLOWING INJECTION OF EVOLYSSE DERMAL FILLERS (FORM AND SMOOTH) AND VITRASE INJECTION PERFORMED ON (B)(6) 2025, BY DR. (B)(6) IN (B)(6). SYMPTOMS OF LEFT-SIDED FACIAL SWELLING AND PAIN BEGAN 2¿3 DAYS POST-INJECTION. THE PATIENT PRESENTED TO MY OFFICE ON (B)(6) 2025 WITH LARGE LEFT FACIAL SWELLING AND SEVERE PAIN. ULTRASOUND EXAMINATION WAS CONSISTENT WITH A LARGE FLUID CYSTIC MASS. ULTRASOUND-GUIDED ASPIRATION WAS PERFORMED ON THAT DAY YIELDING ~8 CC PURULENT DRAINAGE FROM THE LEFT SIDE. SUBSEQUENT EXAM AND ULTRASOUND-GUIDED DRAINAGE OF LEFT AND RIGHT FACIAL ABSCESS WAS PERFORMED SEVERAL MORE TIMES. CULTURES GREW STREPTOCOCCUS ANGINOSUS AND PREVOTELLA. THE PATIENT IS CURRENTLY UNDERGOING THE ANTIBIOTIC THERAPY (INITIALLY AUGMENTIN + CLINDAMYCIN, LATER CHANGED TO AMOXICILLIN + METRONIDAZOLE) AND REMAINS UNDER ACTIVE TREATMENT. PRODUCT INFORMATION PROVIDED BY THE INJECTOR'S OFFICE INDICATES USE OF: EVO-FORM: LOT S2250760085, EXP. 2/28/2027 EVO-SMOOTH: LOT S2251050162, EXP. 2/28/2027 VITRASE: LOT: AU5424B, EXP: 6/2026 NO PHOTOGRAPHS OF THE SYRINGES OR CONFIRMATION OF THE PRODUCT SOURCE HAVE BEEN PROVIDED DESPITE SEVERAL REQUESTS. PRODUCT CONTAMINATION CANNOT BE EXCLUDED, BUT CAUSALITY HAS NOT BEEN ESTABLISHED. THIS REPORT IS SUBMITTED AS A SERIOUS ADVERSE EVENT FOR REGULATORY TRACKING AND MANUFACTURER INVESTIGATION. POSITIVE FOR STREP ANGINOSUS AND PREVOTELLA. HEALTH CODES:1690, 4577, 1994, 1812, 1735. DEVICE CODE: 2993. REFERENCE REPORT: MW5175670.