RELYX UNICEM 2 CEMENT

Additional Manufacturer Narrative

SINCE THIS EVENT ORIGINALLY WAS REPORTED TO HAVE INVOLVED TWO MEDICAL DEVICES, TWO MANUFACTURER REPORTS WERE SUBMITTED UNDER MANUFACTURER REPORT NUMBERS 9611385-2015-00047 AND 9611385-2015-00048. THIS ADDITIONAL REPORT IS BEING FILED TO COVER THE A ADDITIONAL PRODUCT THAT WAS REPORTED TO BE INVOLVED INSTEAD OF THE PREVIOUS TWO DEVICES UNDER THE ORIGINAL MANUFACTURER REPORTS AS NOTED ABOVE.

Description of Event or Problem

ON (B)(6) 2015, A REPRESENTATIVE FROM A DENTAL OFFICE CONTACTED 3M ESPE TO INQUIRE ABOUT PROPER USAGE OF TWO PRODUCTS: 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE ADHESIVE RESIN CEMENT. DURING THE REPORT, THE REPRESENTATIVE INDICATED THAT UP TO FIVE PATIENTS HAVE EXPERIENCED SENSITIVITY WHICH ULTIMATELY RESULTED IN ROOT CANAL TREATMENT. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FOLLOW-UP INFORMATION, NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. UPDATED INFORMATION PROVIDED BY THE REPORTING DENTAL OFFICE ON (B)(6) 2015 NOW SUGGESTS THAT IT IS POSSIBLE NEITHER 3M ESPE RELYX ULTIMATE CEMENT NOR 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE WERE IN USE BY THE PRACTICE WHEN THE REPORTED ROOT CANAL TREATMENTS WERE REQUIRED. THE OFFICE SUGGESTS THAT IT MAY HAVE BEEN 3M ESPE RELYX UNICEM 2 CEMENT AND THEREFORE THIS NEW MEDWATCH REPORT IS BEING FILED FOR THAT PRODUCT.