RELYX ULTIMATE RESIN ADHESIVE CEMENT
Received Nov 20, 2015 · Event occurred Oct 5, 2015
Report 9611385-2015-00093 · MDR key 5238808
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
60 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT INVOLVED TWO 3M ESPE MEDICAL DEVICES, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MANUFACTURER REPORT NUMBER 9611385-2015-00094 DESCRIBES THE SECOND DEVICE, RESPECTIVELY.
Description of Event or Problem
ON (B)(6) 2015, A (B)(6) FEMALE PATIENT, RECEIVED A NON-3M CROWN ON TOOTH #30 SECURED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT ON (B)(6) 2015. THE PATIENT REPORTED SENSITIVITY SYMPTOMS TO THE DENTAL OFFICE ON (B)(6) 2015. THE ROOT CANAL WAS PERFORMED ON (B)(6) 2015. THE DENTAL PROFESSIONAL COMMENTED THAT HE CANNOT WITH 100% CERTAINTY STATE THAT THE SENSITIVITY EXPERIENCED WAS DUE TO THE USE OF THE 3M PRODUCTS.