FDA Adverse Event
Malfunction
Summary report: N
TRADITION PB NON FIBER OPTIC
MDR report key: 392240
·
Received April 29, 2002
Report
- Report Number
- 1419322-2002-00022
- Event Type
- Malfunction
- Date Received
- April 29, 2002
- Report Date
- April 26, 2002
- Manufacturer
- MIDWEST DENTAL PRODUCTS
- Product Code
- EFB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A DENTIST ALLEGES THAT DENTAL BURS CAME OUT OF THE HANDPIECE ON THREE OR FOUR DIFFERENT OCCASIONS. IN ALL INSTANCES THE BURS WERE RETRIEVED AND THERE WERE NO INJURIES TO ANY PT'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRADITION PB NON FIBER OPTIC | DENTAL HANDPIECE | EFB | MIDWEST DENTAL PRODUCTS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |