MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-07 for TYTIN 29951 manufactured by Kerr Corporation.
[5309306]
A doctor's office alleged that two (2) employees had experienced high levels of mercury readings due to the handling and processing of used amalgam. This is the first of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[12655056]
Specific information with regard to patient age, and weight were not provided. It was reported that the doctor's office autoclaved crowns that contains amalgam, sourced the amalgam and scrapped them for over ten (10) years. The employee had experienced a tingling sensation in her hands and fibromyalgia. The employee sought medical attention with a chelation therapist and was diagnosed with high levels of mercury reading of 34. The patient is currently undergoing chelation therapy. The product was not returned and no lot number was provided; therefore, no evaluations can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2015-00001 |
| MDR Report Key | 4394061 |
| Report Source | 05 |
| Date Received | 2015-01-07 |
| Date of Report | 2014-12-16 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2015-01-07 |
| 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 | 2015-01-07 |
| Catalog Number | 29951 |
| 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 | 2015-01-07 |