FYNAL PERMANENT ZOE CEMENT
Received Jun 21, 2017
Report 2515379-2017-00010 · MDR key 6658525
Device
Generic name
Cement, Dental
Manufacturer
Dentsply CaulkModel number
NACatalog number
609001
Lot number
170113
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Swelling
- Hypersensitivity/Allergic reaction
- Swelling
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED ALLERGIC REACTION AFTER UNDERGOING DENTAL TREATMENT WITH FYNAL ZINC OXIDE EUGENOL CEMENT. THE SWELLING SUBSIDED ON IS OWN AND NO MEDICAL INTERVENTION WAS NEEDED.