Description of Event or Problem · 1
THE PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE IN THE AFTERNOON ON (B)(6) 2013. WHEN THE PATIENT WAS INJECTED IN THE CHEEK, SHE WINCED AND (B)(6), RN (INJECTOR) WONDERED IF SHE HIT A NERVE. (B)(6) WENT TO ANOTHER AREA OF THE FACE AND INJECTED BOTOX. SHE SAT THE PATIENT UP. THE PATIENT HAD A VASO-VAGAL REACTION. (B)(6) LAID THE PATIENT DOWN. SHE GAVE THE PATIENT CHOCOLATE AND WATER AS SHE HAD NOT EATEN. THE PATIENT STATED THAT ONE SIDE BY HER EYE FELT NUMB. (B)(6) SAT THE PATIENT BACK UP AND THE PATIENT WAS FINE. THE PATIENT STAYED IN HER OFFICE 10 MORE MINUTES AND THEN WENT HOME. AT HOME THE PATIENT HAD A HEADACHE AND FELT NAUSEOUS WHICH TRIGGER HER TO VOMIT. AT 5:30 PM SHE TOOK IBUPROFEN. THE PATIENT IS A NURSE. THE PATIENT'S HUSBAND IS A DOCTOR AND HE GAVE HER ALTRAM. THAT NIGHT THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS GIVEN MORPHINE BY IV TO RESOLVE THE HEADACHE. WHEN THE PATIENT LOOKED UP AND TO THE RIGHT SHE WAS A LITTLE DIZZY (THE PATIENT'S VISION WAS ASKEW). ALL SYMPTOMS IMPROVED. THE HEADACHE RESOLVED FRIDAY AFTER THE HOSPITAL VISIT. THERE WAS SOME RESIDUAL SWELLING ON THE LEFT CHEEK. AS OF (B)(6) 2013 THERE IS STILL NUMBNESS ON THE LEFT BUT NOT AS NUMB AS BEFORE. THE UPPER LIP AND CHEEK ARE NUMB. CARRIE TOOK PHOTOS (NOT GIVEN TO MERZ AESTHETICS). ON A SCALE OF 1-5 THE RIGHT CHEEK IS A +1 FOR SWELLING AND THE LEFT CHEEK IS A +3 FOR SWELLING. THERE IS LIGHT, MINIMAL BRUISING UNDER BOTH EYES (IT IS BLUE). (B)(6) IS CONCERNED ABOUT VASCULAR COMPROMISE BUT DOES NOT SUSPECT VASCULAR COMPROMISE. THERE IS AN ERYTHEMA PATTERN ON THE LEFT (CAPILLARY REFILL) WITH NO BUMPS. (B)(6), RN SPOKE TO A MERZ AESTHETICS CONTRACTED PHYSICIAN, DR (B)(4). DR (B)(4) PROVIDED A SUMMERY OF THE CALL: IT SOUNDS AS THOUGH HER PATIENT HAS INFRAORBITAL ANESTHESIA. DURING THE PROCEDURE, SHE EITHER NICKED THE NERVE, DEPOSITED THE PRODUCT TOO CLOSE TO THE NERVE OR THE PATIENT DEVELOPED A HEMATOMA WHICH IS COMPRESSING THE NERVE. IT DOES NOT SOUND AS IF SHE HAS ANY VASCULAR COMPROMISE, BUT I HAVE ASKED HER TO KEEP ME UPDATED SHOULD THE CLINICAL FINDINGS CHANGE. INTERESTINGLY, THE TREATMENT SEEMED TO TRIGGER A FIRST TIME MIGRAINE. THE PATIENT HAS RECOVERED FULLY FROM THAT. SHE IS TREATING WITH A MEDROL DOSE PACK AND WILL KEEP ME POSTED IF ANYTHING CHANGES. I DID EXPLAIN THE ANESTHESIA OF THE INFRAORBITAL NERVE CAN BE LONG LASTING BUT ALL REPORTED CASES THAT I AM AWARE OF HAVE RESOLVED COMPLETELY. PER DISCUSSION WITH (B)(6) ON (B)(4) 2013: SHE SAW THE PATIENT THE FOLLOWING MONDAY, (B)(6) 2013 AND GAVE THE PATIENT A MEDROL DOSE PACK. THINGS WERE RESOLVING. THERE WAS A LITTLE NEURALGIA BUT IT WAS COMING BACK. SHE IS DOING BETTER AND THE NEURALGIA IS RESOLVING. THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.