3M ESPE RELYX UNICEM 2 AUTOMIX
Received Oct 28, 2014
Report 9611385-2014-00013 · MDR key 4222954
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
ON (B)(6) 2014, 3M ESPE WAS CONTACTED BY A DENTIST WHO REPORTED THAT FOLLOWING USAGE OF THE 3M ESPE PRODUCT, 3M ESPE RELYX UNICEM 2 AUTOMIX. THREE PTS REQUIRED ENDODONTIC TREATMENT. TWO PTS HAD ROOT CANAL TREATMENTS BEFORE AND HAD TO HAVE THEM RE-DONE. NO OTHER PRODUCTS WERE USED ASIDE FROM 3M ESPE RELYX UNICEM 2 AUTOMIX.
Additional Manufacturer Narrative
EXACT DATA ON THE SYMPTOMS WHICH LED TO THE NECESSITY OF THE ROOT CANAL TREATMENTS WERE NOT GIVEN BY THE DENTIST. THE FACTS THAT THE PROBLEMS OCCURRED IN THREE DIFFERENT PTS AND NO OTHER COMPLAINTS HAVE REACHED US REGARDING THE AFFECTED LOT-NO 551668 MAKES IT DOUBTABLE THAT THERE ARE UNDERLYING ALLERGIC REACTIONS OR MATERIAL DEFECTS. AS IT WASN'T POSSIBLE TO GATHER MORE INFO FROM THE DOCTOR'S OFFICE UNTIL THE TIME OF THIS REPORT, IT CAN'T BE DETERMINED IF A HANDLING ERROR WAS THE REASON FOR THE ADVERSE EVENTS. 3M ESPE RELYX UNICEM 2 AUTOMIX HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE.