MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-12 for SILVER FILLINGS CROWNS OR CEMENT manufactured by .
[1780341]
(b)(6) old fillings (8) of them. Now mouth burning and tongue. Nerves so bad from it - to er, doctors - 5 dentists. In 2009, started having crowns put on 4 of them. Crowns or cement affecting old fillings? I'm sick all the time since (b)(6) 2010. Touch old filling with tongue burns bad! I need help - no one knows what to do! Old fillings hurt - burns. Please help! I'm miserable. Nerves shot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018990 |
| MDR Report Key | 1962611 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-03 |
| Date of Event | 2010-03-01 |
| Date Added to Maude | 2011-01-20 |
| 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 | PATIENT |
| 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 | SILVER FILLINGS CROWNS OR CEMENT |
| Generic Name | NONE |
| Product Code | EJJ |
| Date Received | 2011-01-12 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2011-01-12 |