MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-19 for TYTIN 29946 manufactured by Kerr Corporation.
[2566963]
A customer stated that after mixing a tytin capsule in an amalgamator and opening it up, the mercury was not mixed with the silver powder. The contents spilled out over the operation area.
Patient Sequence No: 1, Text Type: D, B5
[9583133]
No injury was associated with this incident but one mdr is being submitted because if this malfunction were to recur it may lead to inhalation of the unmixed particles by the doctor or patient. No product was returned; an evaluation on the retain sample was performed and found to meet product specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2012-00001 |
| MDR Report Key | 2421579 |
| Report Source | 05 |
| Date Received | 2012-01-19 |
| Date of Report | 2011-12-26 |
| Date of Event | 2011-12-19 |
| Date Mfgr Received | 2011-12-26 |
| Device Manufacturer Date | 2010-09-09 |
| Date Added to Maude | 2012-01-19 |
| 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 | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| 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 | 2012-01-19 |
| Catalog Number | 29946 |
| Lot Number | 0-1238 |
| Device Expiration Date | 2013-09-01 |
| Operator | DENTIST |
| Device Availability | N |
| 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 | 2012-01-19 |