MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-27 for HU-FRIEDY ROOT TIP ELEVATOR E9L manufactured by Hu-friedy.
[1147974]
As the resident was attempting to loosen an embedded tooth the tip of the dental pick broke off in the mandibular bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1465456 |
| MDR Report Key | 1465456 |
| Date Received | 2009-08-27 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-25 |
| Report Date | 2009-08-27 |
| Date Reported to FDA | 2009-08-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HU-FRIEDY |
| Generic Name | SURGICAL DEVICE |
| Product Code | EJB |
| Date Received | 2009-08-27 |
| Model Number | ROOT TIP ELEVATOR |
| Catalog Number | E9L |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HU-FRIEDY |
| Manufacturer Address | 77 JEAN AVE LOWELL MA 01852 US 01852 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-27 |