3M¿ RELYX¿ LUTING PLUS AUTOMIX CEMENT

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO SOLVENTUM FOR ANALYSIS; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. ALLERGIC REACTIONS TO POTASSIUM PERSULFATE OR METHACRYLATES ARE KNOWN HARMS ASSOCIATED WITH THIS PRODUCT. POSSIBLE CAUSE IS PREVIOUSLY UNKNOWN ALLERGIES TO EITHER OF THESE SUBSTANCES. INSTRUCTIONS FOR USE INDICATE THAT ANY SUBSTANCE IN CONTACT WITH PATIENT TISSUE SHOULD BE REMOVED. COMPLAINTS WERE REVIEWED WITH NO ADVERSE TREND OBSERVED. SOLVENTUM WILL CONTINUE TO MONITOR.

Description of Event or Problem

A PATIENT REPORTEDLY HAS MAST CELL ACTIVATION SYNDROME AND EXPERIENCED AN ANAPHYLACTIC REACTION AFTER RELYX¿ LUTING CEMENT TOUCHED HER TONGUE AND GUMS. SYMPTOMS REPORTED WERE A BURNING SENSATION AND SWELLING ON THEIR TONGUE AND GUMS AND DECREASED BREATHING. PATIENT USED THEIR NEFFY SPRAY. THE SYMPTOMS IMPROVED BUT CAME BACK THE NEXT DAY. SHE WENT TO THE EMERGENCY ROOM AND WAS GIVEN STEROIDS.