FDA Adverse Event
Malfunction
Summary report: N
CARBIDE
MDR report key: 2924650
·
Received January 11, 2013
Report
- Report Number
- 2924650
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 11, 2013
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS, LLC
- Product Code
- HBE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
THE BUR BROKE DURING ORAL SURGERY PROCEDURE. THE ATTENDING DOCTOR WAS SURE THAT THE BUR TIP WAS SUCKED IN TO THE WALL SUCTION. THE BURR THAT WAS REMAINING WAS SEQUESTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17002 | CARBIDE | BUR, SURGICAL | HBE | MICROAIRE SURGICAL INSTRUMENTS, LLC | * | 0712205649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |