RELYX LUTING PLUS CEMENT
Received Jul 14, 2016 · Event occurred Jun 16, 2016
Report 3005174370-2016-00073 · MDR key 5797079
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THE PATIENT'S HISTORY SUGGESTS A KNOWN REACTION TO ARTIFICIAL FINGERNAILS. SUCH A REACTION IS OFTEN CONSISTENT WITH AN ALLERGY TO ACRYLATES. AS SOLD, RELYX LUTING CEMENT CONTAINS METHACRYLATE MONOMERS; MANY PATIENTS WHO HAVE ALLERGY TO ACRYLATES EXPERIENCE A CROSS-REACTION TO METHACRYLATES. FOR THIS REASON, THE PRODUCT INSTRUCTIONS FOR USE CONTAIN A WARNING STATEMENT TO AVOID USE IN PATIENTS WITH KNOWN ACRYLATE ALLERGY.
Description of Event or Problem
ON (B)(6) 2016, A (B)(6) FEMALE PATIENT REPORTED SHE EXPERIENCED AN ALLERGIC REACTION (SYMPTOMS OF NUMBNESS AND ROUGHNESS OF TISSUES ON THE LEFT SIDE OF HER MOUTH ACCOMPANIED BY THROAT SWELLING). THESE SYMPTOMS BEGAN AFTER (B)(6) 2016, PLACEMENT OF A NON-3M CROWN ON TOOTH #14 USING 3M ESPE RELYX LUTING PLUS CEMENT. THE PATIENT WAS TREATED AT AN EMERGENCY ROOM WITH AN INJECTION OF BENADRYL® AND RELEASED. SEVERAL DAYS LATER, THE PATIENT DEVELOPED WHAT WAS DESCRIBED AS CANKER SORES IN THE SOFT TISSUE ADJACENT TO THE CROWN; A DEXAMETHASONE MOUTH RINSE WAS PRESCRIBED AND THE SORES RESOLVED.