ENGINEERING INVESTIGATION WAS LIMITED DUE TO LACK OF RETURNED PRODUCT AND LOT NUMBER INFORMATION. THE CAUSE OF THE PATIENT'S SYMPTOMS IS UNKNOWN; MULTIPLE PRODUCTS WERE USED DURING THE DENTAL APPOINTMENT. THIS PRODUCT CONTAINS POTASSIUM PERSULFATE, WHICH CAN TRIGGER AN ALLERGIC RESPIRATORY REACTION IN CERTAIN INDIVIDUALS. ALSO, IN THE UN-CURED STATE, THIS PRODUCT CONTAINS METHACRYLATE RESINS WHICH CAN TRIGGER AN ALLERGIC REACTION IN INDIVIDUALS WITH SENSITIVITIES TO ACRYLIC-BASED MATERIALS. INFORMATION ABOUT THESE POTENTIAL REACTIONS ARE ALREADY PROVIDED IN THE PRODUCT INSTRUCTIONS FOR USE.
D
Patient 1
ON (B)(6) 2017, A DENTIST REPORTED THAT A (B)(6) FEMALE PATIENT EXPERIENCED BREATHING DIFFICULTY UPON USE OF 3M ESPE RELYX LUTING PLUS CEMENT TO SEAT CROWN ON TOOTH #3. JUST PRIOR TO THE CROWN SEATING, THE PATIENT ALSO HAD A COMPOSITE RESTORATION PROCEDURE PERFORMED ON TOOTH #2. OTHER PRODUCTS USED INCLUDED AN ANESTHETIC, A PROPHY PASTE, AND A NON-3M BRAND COMPOSITE MATERIAL. THE DENTAL OFFICE ADMINISTERED OXYGEN AND CALLED FOR EMERGENCY MEDICAL ASSISTANCE. THE PARAMEDIC ADMINISTERED THE EPIPEN THAT THE PATIENT NORMALLY CARRIES. THE PATIENT WAS THEN TAKEN TO THE ER, WAS ADMITTED FOR OBSERVATION AND WAS DISCHARGED THE NEXT DAY.