MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-30 for PARTIAL DENTURE manufactured by Dentsply International.
[3165436]
Pt used dentures for three weeks. When she started experiencing high fever, weakness, mouth sores, dehydration, dry mouth and loss of appetite. She immediately discontinued using the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030006 |
| MDR Report Key | 3088886 |
| Date Received | 2013-04-30 |
| Date of Report | 2013-04-30 |
| Date of Event | 2013-03-01 |
| Date Added to Maude | 2013-05-03 |
| 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 | PARTIAL DENTURE |
| Generic Name | DENTSPLY PROSTHETIC |
| Product Code | EBI |
| Date Received | 2013-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2013-04-30 |