MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-09 for TYTIN 29948 manufactured by Kerr Corporation.
[4278207]
A doctor alleged that the tytin amalgam was too grainy and hard to condense during procedures for three (3) patients. This is the second of three (3) reports.
Patient Sequence No: 1, Text Type: D, B5
[11820715]
Specific information with regard to patient gender, age, and weight were not provided. The doctor removed the amalgam and repeated the procedure, without further incident. To date, the patient is doing fine. The product was not returned; therefore, a physical evaluation was performed on a retained sample of the product, yielding results within specification for carve time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2014-00003 |
| MDR Report Key | 3736180 |
| Report Source | 05 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-03-10 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-06-03 |
| 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 | 2014-04-09 |
| Catalog Number | 29948 |
| Lot Number | 3-1221 |
| Device Expiration Date | 2016-08-31 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-04-09 |