CALIBRA ESTHETIC RESIN CEMENT
Received Mar 18, 2015
Report 2515379-2015-00017 · MDR key 4620609
Device
Generic name
Dental Cement
Manufacturer
Dentsply CaulkModel number
NACatalog number
607060
Lot number
131111
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
IN THIS EVENT A PT REPORTED THAT THEY HAD SEEN A MAXILLO FACIAL SPECIALIST AND WHO REFERRED THE PT FOR ALLERGY TESTING BECAUSE THE PT'S MOUTH HAS BEEN VERY PAINFUL SINCE HAVING VENEERS FITTED USING CALIBRA CEMENT. OUTCOME IS UNK AS OF THIS MDR EVAL. FOLLOW UP IS NOT YET COMPLETE.
Additional Manufacturer Narrative
WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDANT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE OF THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.