DYCAL RADIOPAQUE CALCIUM HYDROXIDE COMPOSITION
Received Oct 17, 2019
Report 2515379-2019-00030 · MDR key 9205359
Device
Generic name
Liner, Cavity, Calcium Hydroxide
Manufacturer
Dentsply CaulkModel number
NACatalog number
623451Y-6
Lot number
171201
Product problems
- Defective Device
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Sensitivity of Teeth
- No Code Available
- Sensitivity of Teeth
- No Code Available
Narrative
Additional Manufacturer Narrative
RETAINED DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative
THEREFORE, BECAUSE MEDICAL/SURGICAL INTERVENTION WAS REQUIRED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ADVERSE REACTION AFTER UNDERGOING A ROUTINE RESTORATIVE PROCEDURE WITH DYCAL AS ONE OF THE COMPONENTS. AN INDIRECT PULP CAPPING PROCEDURE WAS PERFORMED, AND THE TOOTH EVENTUALLY NEEDED ENDODONTIC TREATMENT. THE DENTIST CLAIMS THAT ENDODONTIC THERAPY HAD TO BE PERFORMED DUE TO THE MALFUNCTION OF THE DYCAL.