MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for TYTIN 29949 manufactured by Kerr Corporation.
[110577443]
No patient information in regards to age, weight, ethnicity, and race was provided. The date of event is estimated because the exact day was not provided. An evaluation of the product is expected but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[110577444]
An alleged complaint was reported that a patient was experiencing pain and the doctor had to remove the amalgam. It was noted that th bottom of the amalgam looked like "gravel" as if it has never set. The amalgam was placed (b)(6) 2011 the patient's tooth had to be extracted. No additional injuries or medical intervention was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1815757-2018-00004 |
| MDR Report Key | 7584843 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2018-06-08 |
| Date Added to Maude | 2018-06-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| 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 | 0 |
| Brand Name | TYTIN |
| Generic Name | DENTAL AMALGAM CAPSULE |
| Product Code | EJJ |
| Date Received | 2018-06-08 |
| Catalog Number | 29949 |
| Lot Number | 5-1092 |
| Operator | DENTIST |
| Device Availability | * |
| 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 | 2018-06-08 |