MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-30 for ASPEN DENTAL manufactured by Unk.
[59011360]
(b)(6) was diagnosed (b)(6) dental with several cavities and several teeth that needed to be extracted. Instead, ms. (b)(6) went to (b)(6) dental, (b)(6) and had all her teeth removed and upper/lower dentures placed. Ms. (b)(6) then complained bitterly that the upper/lower dentures do not stay in and were useless. At this point, the only solution are implants in the jaw to help with stability of the upper/lower dentures. A thorough exam and full mouth radiographs were taken at (b)(6) dental (b)(6) 2014. Quite a few teeth could be salvaged and could have been kept. (b)(6) dental decided to remove all teeth and place upper and lower denture. (b)(6) dental does wholesale extractions, whether, necessary or not. (b)(6) dental extracted all teeth on (b)(6) 2015, and placed a completely worthless upper and lower denture, for (b)(6). The tragedy is quite a few teeth could have been saved, and ms. (b)(6) would not be in this predicament.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065739 |
| MDR Report Key | 6069553 |
| Date Received | 2016-10-30 |
| Date of Report | 2016-10-30 |
| Date of Event | 2016-05-23 |
| Date Added to Maude | 2016-11-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ASPEN DENTAL |
| Generic Name | UPPER/LOWER DENTURE |
| Product Code | NSL |
| Date Received | 2016-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-30 |