FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1233963
·
Received November 19, 2008
Report
- Report Number
- 1419798-2008-00022
- Event Type
- Injury
- Date Received
- November 19, 2008
- Report Date
- October 22, 2008
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WHILE THE DENTIST WAS WORKING ON TOOTH #22 AND #23, THE PATIENT'S LIP WAS BURNED ABOUT THE SIZE OF A DIME.
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 |