RELYX LUTING PLUS AUTOMIX CEMENT
Received Mar 8, 2016
Report 3005174370-2016-00031 · MDR key 5487670
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Anaphylactic Shock
- Anaphylactic Shock
Narrative
Additional Manufacturer Narrative
ENGINEERING INVESTIGATION WAS LIMITED DUE TO LACK OF RETURNED PRODUCT AND LOT NUMBER INFORMATION. THIS EVENT INVOLVED TWO 3M ESPE MEDICAL DEVICES, THEREFORE TWO MANUFACTURER MEDWATCH REPORTS ARE BEING SUBMITTED. THIS MEDWATCH REPORT PROVIDES INFORMATION ON THE SECOND MEDICAL DEVICE. MANUFACTURER REPORT 9611385-2016-00003 PROVIDES INFORMATION ON THE FIRST MEDICAL DEVICE. BOTH 3M SUBJECT PRODUCTS HAVE BEEN EVALUATED FOR BIOCOMPATIBILITY AND ARE SAFE FOR THEIR INTENDED USE. WITHOUT ADDITIONAL INFORMATION ON PATIENT MEDICAL HISTORY, THE CAUSE OF THE REPORTED REACTION CANNOT BE DETERMINED. RELYX LUTING PLUS AUTOMIX CEMENT CONTAINS POTASSIUM PERSULFATE WHICH CAN TRIGGER AN ALLERGIC RESPIRATORY REACTION IN CERTAIN PRE-SENSITIZED INDIVIDUALS (THOSE INDIVIDUALS ALREADY SENSITIZED TO SULFITES). THE INSTRUCTIONS FOR USE FOR RELYX LUTING PLUS AUTOMIX CEMENT AND SAFETY DATA SHEET BOTH CONTAIN A WARNING FOR THE POTENTIAL CROSS-REACTION. IN THE LAST SEVEN YEARS, 3M HAS RECEIVED ONLY THREE OTHER REPORTS OF POSSIBLE RESPIRATORY REACTION FOR THE PRODUCT.
Description of Event or Problem
A MEDICAL OFFICE REPORTED A (B)(6) PATIENT EXPERIENCED ANAPHYLACTIC SHOCK AFTER USE OF 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX LUTING PLUS AUTOMIX CEMENT. CONTACT INFORMATION FOR THE MEDICAL OFFICE WAS INADVERTENTLY NOT OBTAINED DURING THE CALL. 3M CONTACTED THE TREATING DENTAL OFFICE AND THEY WERE UNABLE TO IDENTIFY THE PATIENT INVOLVED IN THIS CASE; THEREFORE NO FURTHER INFORMATION IS AVAILABLE, AND THE RELATIONSHIP OF THE SYMPTOMS REPORTED TO USE OF THE 3M SUBJECT PRODUCTS CANNOT BE ESTABLISHED.