FDA Adverse Event
Other
Summary report: N
MEDI-PLUS
MDR report key: 731935
·
Received February 6, 2006
Report
- Report Number
- 731935
- Event Type
- Other
- Date Received
- February 6, 2006
- Date of Event
- November 15, 2005
- Report Date
- February 6, 2006
- Manufacturer
- BRASSELER USA
- Product Code
- DZA
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT OR GNETA (GENERAL ENDOTRACHEAL ANESTHESIA) FOR THE EXTRACTION OF AN IMPACTED WISDOM TOOTH. THE TIP OF THE TAPERED CARBIDE BUR WAS NOTICED TO BE MISSING FROM THE SHAFT BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDI-PLUS | TIP, DENTAL | DZA | BRASSELER USA | 04CO607 | Z9296 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | NO OTHER THERAPIES |