MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-20 for TYTIN 29952 manufactured by Kerr Corporation.
[3928849]
A doctor alleged that the tytin amalgam did not set up after placement in a patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
[11085112]
Specific information with regard to patient age and weight were not provided. The doctor removed the amalgam and repeated the procedure using a different product, without further incident. To date, the patient is doing fine. The product was not returned; therefore, a visual and chemical test was performed on a retained sample, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
[11367421]
A visual and physical test was performed on the returned product. Three (3) out of the eighty (80) capsules tested did not meet specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2013-00010 |
| MDR Report Key | 3360863 |
| Report Source | 05 |
| Date Received | 2013-09-20 |
| Date of Report | 2013-08-22 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-12-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 28200 WICK ROAD |
| Manufacturer City | ROMULUS MI 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYTIN |
| Generic Name | DENTAL AMALGAM CAPSULE |
| Product Code | DZS |
| Date Received | 2013-09-20 |
| Catalog Number | 29952 |
| Lot Number | 2-1073 |
| Device Expiration Date | 2015-03-31 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 28200 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-09-20 |