FDA Adverse Event
Injury
Summary report: N
HALL MICRO CHOICE HIGH SPEED DRILL
MDR report key: 99569
·
Received June 19, 1997
Report
- Report Number
- 33458-1997-00004
- Event Type
- Injury
- Date Received
- June 19, 1997
- Date of Event
- June 9, 1997
- Report Date
- June 17, 1997
- Manufacturer
- LINVATEC
- Product Code
- DZI
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A PROCEDURE TO REMOVE 2 LOWER WISDOM TEETH, THE MICRO CHOICE HIGH SPEED DRILL, 5020-025, WITH MEDIUM BURR GUARD, 5020-060, SN OCT 96 OVERHEATED CAUSING A BURN APPROX 2 X 1 CM TO THE PTS LOWER LIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALL MICRO CHOICE HIGH SPEED DRILL | DRILL | DZI | LINVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |