FDA Adverse Event
Injury
Summary report: N
MIRA LUX MULTIFLEX TURBINE 635B
MDR report key: 1033908
·
Received April 24, 2008
Report
- Report Number
- 1419798-2008-00007
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 27, 2008
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EKX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BUR CAME OUT OF HANDPIECE AND LODGED IN PATIENT'S THROAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRA LUX MULTIFLEX TURBINE 635B | DENTAL HANDPIECE AND ACCESSSORIES | EKX | KALTENBACH & VOIGT GMBH | 635B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |