FDA Adverse Event
Malfunction
Summary report: N
TRADITION
MDR report key: 392362
·
Received April 29, 2002
Report
- Report Number
- 1419322-2002-00014
- Event Type
- Malfunction
- Date Received
- April 29, 2002
- Date of Event
- April 17, 1998
- Report Date
- April 26, 2002
- Manufacturer
- MIDWEST DENTAL PRODUCTS
- Product Code
- EFB
- Removal / Correction Number
- 1013695
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A DENTIST ALLEGES THAT A DENTAL BUR CAME OUT OF HTE HANDPIECE, JUMPED TO THE BACK OF THE THROAT, AND WAS SUBSEQUENTLY SWALLOWED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRADITION | DENTAL HANDPIECE | EFB | MIDWEST DENTAL PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Other |