Description of Event or Problem · 1
THE INITIAL INFORMATION WAS RECEIVED ON (B)(6) 2010. THIS WAS REPORTED BY A DENTAL OFFICE FOR THE DENTIST. ON (B)(6) 2010, AT THE DENTAL OFFICE, PREVIDENT 5% SODIUM FLUORIDE VARNISH WAS APPLIED TO THE TEETH OF A (B)(6) FEMALE, WHO HAS ALLERGIES TO PALM OIL, COLOPHONY AND ROSIN. WHILE APPLYING THIS PRODUCT, THE PT EXPERIENCED TINGLING IN HER MOUTH AND LIP SWELLING. WHEN THE PT LEFT THE DENTAL OFFICE, SHE WAS STILL EXPERIENCING THE TINGLING MOUTH AND SWOLLEN LIPS. ON (B)(6) 2010, THE PT REPORTED WAKING UP IN THE MORNING WITH SWELLING TO HER FACE, LIPS AND TONGUE. SHE WAS TAKEN TO A LOCAL EMERGENCY ROOM (LENGTH OF STAY UNKNOWN) THAT SAME DAY WHERE AN EPI PEN WAS ADMINISTERED FOR THE ALLERGIC REACTION. THE PT WAS DISCHARGED FROM THE EMERGENCY ROOM (DATE UNKNOWN) WITH A PRESCRIPTION FOR ORAL PREDNISONE AND AN UNSPECIFIED MEDICATION (DOSAGE AND FREQUENCY UNKNOWN). AS OF THE DATE OF THE REPORT, THE PT WAS HOME, BUT THE STATUS OF HER SYMPTOMS WAS UNKNOWN. FOLLOW-UP INFORMATION OBTAINED (B)(6) 2010. THE REPORTER CONFIRMED THAT THE EVENTS EXPERIENCED BY THE PT WERE CONSIDERED TO BE MEDICALLY IMPORTANT AND THE EVENTS WERE LIKELY DUE TO THE PRODUCT. AT THE TIME OF THIS REPORT, THE PT WAS DOING FINE AND CONTINUES TO TAKE PREDNISONE.