InjuryEMA
RELYX U200 CEMENT
Received Jun 9, 2016
Report 9611385-2016-00007 · MDR key 5710921
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
46 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS EXPECTED TO BE RETURNED TO 3M FOR EVALUATION. IF THE SAMPLE IS RETURNED AND EVALUATION RESULTS BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
ON (B)(6) 2016, A DENTIST FROM (B)(6) REPORTED TO 3M THAT A PATIENT WAS RECOMMENDED FOR ENDODONTIC TREATMENT. THIS PATIENT EXPERIENCED PERSISTENT SENSITIVITY (FOR APPROXIMATELY 2 MONTHS) FOLLOWING PLACEMENT OF A CROWN (MANUFACTURER UNKNOWN) USING 3M EPSE RELYX U200 CEMENT (ALSO KNOWN AS RELYX UNICEM 2 CEMENT).