MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-27 for TYTIN FC 26467 (ITEM #) manufactured by Kerr Corp. Kerr Usa.
[194270]
"during the trituration process free elemental mercury escaped from a cartridge and was disbursed in my working environment. This is a very serious health hazard. This incident could lead to mercury poisoning. There was no pt involvement. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017060 |
| MDR Report Key | 237844 |
| Date Received | 1999-08-27 |
| Date of Report | 1999-08-27 |
| Date of Event | 1999-08-13 |
| Date Added to Maude | 1999-09-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYTIN FC |
| Generic Name | CARTRIDGE FOR MIXING |
| Product Code | EHE |
| Date Received | 1999-08-27 |
| Model Number | NA |
| Catalog Number | 26467 (ITEM #) |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 230489 |
| Manufacturer | KERR CORP. KERR USA |
| Manufacturer Address | 28200 WICK RD. ROMULUS MI 481742600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-27 |