RELYX LUTING PLUS AUTOMIX CEMENT
Received Sep 29, 2017 · Event occurred Sep 7, 2017
Report 3005174370-2017-00047 · MDR key 6906290
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR
- Swelling
- Tissue Breakdown
- Swelling
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
ENGINEERING INVESTIGATION WAS LIMITED DUE TO LACK OF RETURNED PRODUCT AND LOT NUMBER INFORMATION. THE 3M SUBJECT PRODUCT HAS BEEN EVALUATED FOR BIOCOMPATIBILITY AND IS SAFE FOR INTENDED USE. IN ADDITION, THE INSTRUCTIONS FOR USE (IFU) CONTAINS PRECAUTIONARY INFORMATION ABOUT POTENTIAL ALLERGIC REACTION FOLLOWING ORAL SOFT TISSUE OR SKIN CONTACT WITH THE PRODUCT.
Description of Event or Problem
A DENTIST REPORTED THAT A (B)(6) MALE PATIENT EXPERIENCED AN ALLERGIC REACTION THAT INCLUDED LIP SWELLING AND GINGIVAL TISSUE SLOUGHING FOLLOWING USE OF 3M ESPE RELYX LUTING PLUS AUTOMIX CEMENT TO PLACE 6 PORCELAIN-FUSED-TO-METAL CROWNS ON (B)(6) 2017. THE PATIENT SOUGHT MEDICAL ATTENTION THAT SAME EVENING, AT AN EMERGENCY ROOM, AND WAS TREATED WITH IV STEROIDS (UNKNOWN) AND BENADRYL. THE DENTIST SAW THE PATIENT 12 DAYS LATER AND THE SYMPTOMS HAD RESOLVED. THE DENIST REPORTED THAT THE CEMENT WAS OVERLOADED ON THE CROWNS AND CAME IN CONTACT WITH THE GUMS AND GINGIVAL TISSUE, AND HE BELIEVES THAT CAUSED THE REACTION. LATEX GLOVES WERE ALSO USED DURING THE APPOINTMENT, BUT IT IS UNKNOWN IF LATEX MAY HAVE CONTRIBUTED TO THE SYMPTOMS.