MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-05 for UNK manufactured by Unk.
[187507]
Began experiencing numbness and pain below a tooth in which rptr had a root canal done in a number of years ago. The numbness radiated out to complete jaw area, lips, and tongue. An endodontist attempted a retreatment of the tooth which was unsuccessful and tooth was extracted. Numbness increased to jaw areas. Numbness still persists after 5 months. This writer feels unsafe endodontic materials were used and these materials leeched into blood stream after tooth deteriorated causing parethesia and pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019888 |
| MDR Report Key | 295744 |
| Date Received | 2000-09-05 |
| Date of Report | 2000-08-28 |
| Date of Event | 2000-03-27 |
| Date Added to Maude | 2000-09-15 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | NA |
| Product Code | EKK |
| Date Received | 2000-09-05 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 286265 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2000-09-05 |