TEMPBOND NE

Description of Event or Problem

A DOCTOR'S OFFICE HAD ALLEGED THAT A PATIENT HAD EXPERIENCED AN ALLERGIC REACTION TWO (2) DAYS AFTER A DENTAL PROCEDURE IN WHICH THE TEMPBOND NE AND TAKE 1 ADVANCED TRAY, TAKE 1 ADVANCED WASH, AND TAKE 1 ADVANCED BITE REGISTRATION MATERIALS WERE UTILIZED.

Additional Manufacturer Narrative

THE REACTION INITIALLY BEGAN AS AN ITCHY RASH ON BOTH HIPS, THIGHS, AND LEGS. TWO (2) DAYS LATER, SHE DEVELOPED A FEVER, COUGHING, AND TROUBLE BREATHING. THE PATIENT SOUGHT FURTHER MEDICAL ATTENTION AT THE ER ON (B)(6), 2015 FOR TREATMENT AND WAS ADMINISTERED AN EPIPEN, VENTOLINE INHALATIONS, AND AN INJECTION OF XOLAIR. SHE WAS THEN ADMITTED TO THE INTENSIVE CARE UNIT, AND WAS ADMINISTERED SOLU-MEDROL, TAVEGYL AND CONTINUED VENTOLINE INHALATIONS. SHE WAS ALSO GIVEN A HIGH DOSE OF PREDNISOLONE FOR THE RASH FOR 10 DAYS, AND TELFAST TABLETS FOUR (4) TIMES DAILY. THE TOOTH FILLING WAS REMOVED ON (B)(6) 2015, AND IT WAS REPORTED THAT THE RASH DISSIPATED. A STEROID CREAM (ELOCON) WAS PRESCRIBED FOR USE ON THE RASH. A VISUAL EVALUATION AND BLOOD TESTS WERE PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH A PHARMOCOLOGICAL ALLERGIC REACTION. THE PATIENT WAS IN THE HOSPITAL FOR A TOTAL OF TWO (2) WEEKS. TO DATE, THE PATIENT HAS RECOVERED AND IS DOING FINE. IT WAS REPORTED THAT OTHER DENTAL PRODUCTS WERE ALSO USED DURING THE PROCEDURE; HOWEVER, IT WAS NOT KNOWN WHICH ONE MAY HAVE CAUSED THE REACTION. THE PATIENT IS CURRENTLY SEEKING FURTHER MEDICAL ATTENTION WITH AN ALLERGIST TO DETERMINE THE CAUSE OF THE INCIDENT. AN UPDATE WILL BE PROVIDED WHEN NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.