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.
[110923808]
No patient information in regards to age, weight, sex, ethnicity, and race was provided. An evaluation of the product is expected but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[110923809]
An alleged complaint was reported that a doctor discovered some capsules have no mercury pillow pack and some capsules have two mercury pillow packs over several years. The doctor is concerned about the capsules with more than one pillow pack and the effect that it is having on the patient's restorations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1815757-2018-00002 |
| MDR Report Key | 7583664 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-07 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2016-05-10 |
| 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 | 6-1131 |
| Device Expiration Date | 2019-05-30 |
| 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 | 2018-06-08 |