MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for COMPUTER GENERATED BRIDGE AND CROWN manufactured by Unk.
[94408847]
Pt reported area of dental bridge and crown was very sensitive and caused him pain to the point that they had to take it out and replaced it with a commercial type dental bridge and crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073858 |
| MDR Report Key | 7101207 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-08-01 |
| Date Added to Maude | 2017-12-08 |
| 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 | COMPUTER GENERATED BRIDGE AND CROWN |
| Generic Name | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Product Code | EBG |
| Date Received | 2017-12-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-07 |