TYTIN
Received Oct 16, 2014
Report 1815757-2014-00011 · MDR key 4178731
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO PATIENT AGE AND WEIGHT WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED SENSITIVITY. UPON THE PATIENT'S RETURN VISIT, THE DOCTOR REMOVED THE AMALGAM AND REPEATED THE PROCEDURE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED; THEREFORE, A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON A RETAIN SAMPLE, YIELDING RESULTS WITHIN SPECIFICATION FOR THE CARVE TIME.
Description of Event or Problem
A DOCTOR ALLEGED THAT THE TYTIN AMALGAM WAS SETTING UP TOO QUICKLY DURING PROCEDURES FOR MULTIPLE PATIENTS. THIS IS THE FIRST OF THREE (3) REPORTS.