MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-26 for DENTAL TOOL * manufactured by Pmi.
[1262781]
Dental instrument broke, tip of instrument was in patient's bone. Surgical team took xray and removed tip of instrument. All pieces were removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1465454 |
| MDR Report Key | 1465454 |
| Date Received | 2009-08-26 |
| Date of Report | 2009-08-26 |
| Report Date | 2009-08-26 |
| Date Reported to FDA | 2009-08-26 |
| Date Added to Maude | 2009-09-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL TOOL |
| Generic Name | DENTAL TOOL |
| Product Code | EJB |
| Date Received | 2009-08-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PMI |
| Manufacturer Address | 2205 WATERSON TRAIL LOUISVILLE KY 40299 US 40299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-26 |