FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1232848
·
Received November 18, 2008
Report
- Report Number
- 1419798-2008-00023
- Event Type
- Injury
- Date Received
- November 18, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 7, 2008
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- KY, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WHILE THE DENTIST WAS WORKING ON TOOTH #1, #2 AND #30, THE PATIENT'S LOWER LIP WAS BURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPA | DENTAL HANDPIECE AND ACCESSORIES | EFB | KALTENBACH & VOIGT GMBH | 25LPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |