Description of Event or Problem · 1
THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (19B045) BY (B)(6) (RN) ON (B)(6) 2019 INTO THE LIPS. TOTAL 1.0 ML OF THE PRODUCT WAS INJECTED, 0.8 ML TO R AND L MANNEQUIN LINES AND 0.2 ML TO R AND L UPPER LIP VERMILLION BORDER AREA. THE PATIENT BEGAN EXPERIENCING SWELLING ON HER FACE AND LIPS APPROXIMATELY 5 DAYS AFTER REVANESSE VERSA+ INJECTIONS. THE SYMPTOMS CONTINUED WITH IRREGULAR, RED ITCHY RASH/WELTS ON HER TORSO AND NECK PARTICULARLY IN THE EARLY MORNING HOURS. PATIENT WENT TO LOCAL EMERGENCY FOR A BLOOD PANEL WHERE NOTHING UNUSUAL WAS FOUND AND THEY PRESCRIBED THE PREDNISONE 20 MG AND LORATADINE 10 MG MEDICINES FOR HER SYMPTOMS. ON (B)(6) 2019 PATIENT CALLED NURSE INJECTOR AND INFORMED HER THAT SHE HAD TO TAKE THE MEDICINES DAILY TO RELIVE HER SYMPTOMS. IF SHE MISSED A DAY THE BREAKOUT WOULD RETURN. PATIENT ASKED IF NURSE INJECTOR COULD REVERSE THE PRODUCT. BEFORE STARTING FOR ANY OTHER TREATMENT, PATIENT WANTED TO SEE AN ALLERGIST SO SHE WENT TO THE ALLERGIST ON (B)(6) 2019, WHERE NOTHING UNUSUAL WAS FOUND. PATIENT CAME TO SEE THE NURSE INJECTOR ON (B)(6) 2019 AND THE NURSE INJECTOR INJECTED THE SAME TREATMENT SITES WITH HYALURONIDASE, 1.5 ML TO EACH SIDE OF HER MANNEQUIN LINES AND 0.5 ML TO EACH SIDE OF UPPER LIP. AFTER THE HYALURONIDASE TREATMENT, THERE WERE NO BREAKOUTS AND SHE DID NOT TAKE ANY MEDICINES. ON (B)(6) 2019 THE PATIENT REPLACED THE DISSOLVED FILLER WITH JUVEDERM PRODUCT.