MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-01 for DENTURES manufactured by .
[27832585]
I am a pt at (b)(6). They made me improperly fitted dentures, and the teeth they filed down under the dentures turned black. Instead of making me new ones they are advising me to use denture cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056871 |
| MDR Report Key | 5131083 |
| Date Received | 2015-10-01 |
| Date of Report | 2015-10-01 |
| Date of Event | 2015-04-15 |
| Date Added to Maude | 2015-10-07 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DENTURES |
| Generic Name | DENTURES |
| Product Code | KOO |
| Date Received | 2015-10-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-01 |