MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-02 for * UNK manufactured by Unk.
[469149]
Pt had a new set of dentures made for her for both the upper and lower jaws. On using the device her mouth was sore and the dentures cut into her gums. The cut dentures were rough and sharp. Pt now uses the old denture she had.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038173 |
| MDR Report Key | 689834 |
| Date Received | 2006-03-02 |
| Date of Report | 2006-03-02 |
| Date of Event | 2006-03-01 |
| Date Added to Maude | 2006-03-21 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | DENTURES |
| Product Code | NSL |
| Date Received | 2006-03-02 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 679011 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-02 |