MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-05 for UPPER PLATES manufactured by Aspen Dental.
[15625586]
I (b) (6) bought upper denture from aspen dental in or about (b) (6) 2010. I am having major problem with the teeth when in put them in my mouth, i get sick to my stomach, headache, ring in the room, i hear ring in the bedroom with the teeth in. I need help with a resolution to this problem with aspen dental in ft. Wayne. Also can we have a phone conference. (b) (6). Diagnosis or reason for use: new upper plates. I had a lot of side effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015913 |
| MDR Report Key | 1686062 |
| Date Received | 2010-05-05 |
| Date of Report | 2010-05-05 |
| Date of Event | 2010-04-15 |
| Date Added to Maude | 2010-05-17 |
| 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 | UPPER PLATES |
| Generic Name | UPPER DENTAL |
| Product Code | NSL |
| Date Received | 2010-05-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN DENTAL |
| Manufacturer Address | FT WAYNE IN US |
| Brand Name | UPPER DENISTER |
| Generic Name | NONE |
| Product Code | NSL |
| Date Received | 2010-05-05 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ASPEN DENTAL |
| Manufacturer Address | FT WAYNE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-05-05 |