TYTIN
Received Jul 8, 2014
Report 1815757-2014-00006 · MDR key 3919314
Device
Product problems
- Nonstandard Device
- Device Operates Differently Than Expected
- Material Integrity Problem
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT THE TYTIN AMALGAM WAS SETTING TOO QUICKLY DURING A PATIENT PROCEDURE.
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO PATIENT AGE AND WEIGHT WERE NOT PROVIDED. THE DOCTOR'S OFFICE COULD NOT RECALL SPECIFIC PATIENT OR INCIDENT DETAILS. THE PATIENT HAD EITHER EXPERIENCED A CRACKED FILLING OR THE LOSS OF A FILLING. UPON THE PATIENT'S RETURN VISIT, THE DOCTOR REPLACED THE FILLING USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. LOT NUMBER 3-1294 HAS BEEN IDENTIFIED AS AN AFFECTED LOT IN AN ONGOING TYTIN RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.
Remedial action
- Recall