3M ESPE RELYX ULTIMATE
Received Oct 8, 2014 · Event occurred Apr 9, 2014
Report 9611385-2014-00012 · MDR key 4182114
Device
Generic name
Cement, Dental
Manufacturer
3m Deutschland GmbhCatalog number
56892 (DENTAL KIT)
Lot number
512586
Product problems
- Patient-Device Incompatibility
Patient
70 YR
- Wound Infection
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 PRODUCTS 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE, A FEMALE PATIENTS REQUIRED ENDODONTIC TREATMENT TO ADDRESS SENSITIVITY. THE DENTAL TREATMENT WAS DONE ON (B)(6) 2014. SUBSEQUENTLY FIVE TEETH WERE TREPANED AND DEVITALIZED (ONE TOOTH AT POSITION 34 ON (B)(6) 2014, THREE TEETH AT POSITIONS 42, 41, 33 ON (B)(6) 2014. AND ONE TOOTH AT POSITION 31 ON (B)(6) 2014).
Additional Manufacturer Narrative
THIS INCIDENT APPEARS TO BE RELATED TO AN ALLERGIC REACTION TO THE DENTAL PRODUCTS. AN EPICUTANE TEST AGAINST THE PRODUCTS SHOWED A MILD REACTION AFTER 72 HOURS. THE 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE HAVE BEEN ACCESSED FOR BIOCOMPATIBILITY AND HAVE BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. THE FIRST SUSPECT MEDICAL DEVICE IS DESCRIBED IN MANUFACTURER REPORT NUMBER 9611385-2014-00011.