MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-03 for TOOTH BRIDGE UNK manufactured by Unk.
[1128785]
I went to a dental clinic and got a nickle. The dentist won't disclose what material at the time- bridge installed in 2006. Since then, periodontal problem developed and became more serious recently around that area. The tooth right next to the bridge had been taken out in 2009. Dose: tbd. Frequency: always. Route: dental. Dates of use: 2006 - 2009. Diagnosis: missing one tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010953 |
| MDR Report Key | 1374447 |
| Date Received | 2009-05-03 |
| Date of Report | 2009-05-03 |
| Date of Event | 2008-05-10 |
| Date Added to Maude | 2009-05-12 |
| 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 |
| 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 | TOOTH BRIDGE |
| Generic Name | TOOTH BRIDGE |
| Product Code | NSN |
| Date Received | 2009-05-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-03 |