MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-28 for NICKEL CROWN manufactured by Na.
[17369746]
A dental clinic installed a nickel-without disclosure- crown in my mouth in 2006. Since then, it developed some serious problems. Some of them are visible. Such as: my face and neck area is itching all the time and shows some dark brown marks on the skin; coughing never stops; periodontal problem around crown area; uncomfortable feeling around kidney area. Etc. Dates of use: 2006 - 2009. Diagnosis or reason for use: cover broken tooth. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010899 |
| MDR Report Key | 1372229 |
| Date Received | 2009-04-28 |
| Date of Report | 2009-04-28 |
| Date of Event | 2008-10-18 |
| Date Added to Maude | 2009-05-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | NICKEL CROWN |
| Product Code | ELZ |
| Date Received | 2009-04-28 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-04-28 |