MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for DENTURES FULL manufactured by Unk.
[124965779]
(b)(6) contracted to fabricate bar-retained, implant-supported full arch upper denture. After he insisted on extracting remaining teeth leaving me edentulous, but defrauded me with denture with flaws. He deliberately created and refused to correct despite harm and taking my money. Implant retained full arch screw-in upper denture fabricated from acrylic teeth on a card. Heavily patched area is sharp, cuts tongue, big lump of plastic and filed area impairs speech, sucking on area causes headaches, neck pain, gum pain/infection, obstructive airway. (b)(6). Refer to letter to (b)(6), united states food and drug administration which includes documentation and pictures. (b)(6) 2018-on advisement inspector general us consumer product safety commission.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080752 |
| MDR Report Key | 7995149 |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-21 |
| Date of Event | 2013-10-07 |
| Date Added to Maude | 2018-10-23 |
| 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 FULL |
| Generic Name | DENTURES FULL |
| Product Code | NSL |
| Date Received | 2018-10-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-22 |