IRM CEMENT

Additional Manufacturer Narrative

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. IN CASE OF ALLERGIC REACTIONS NO TESTS IN QC IS POSSIBLE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT EXPERIENCED SYMPTOMS SUCH AS HEADACHE, SEVERE MIGRAINES, DIZZINESS, AND IRREGULAR BLOOD PRESSURE, AFTER THE USE OF IRM CEMENT. THE DENTIST REMOVED THE IRM PLASTER, AND SYMPTOMS DISAPPEARED ON THE SAME DAY.