FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1369723
·
Received April 29, 2009
Report
- Report Number
- 1419798-2009-00010
- Event Type
- Injury
- Date Received
- April 29, 2009
- Report Date
- April 2, 2009
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MO, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A PATIENT'S CHEEK WAS BURNED TO THE SIZE OF A QUARTER, WHILE THE DENTIST WAS WORKING ON AN UPPER MOLAR.
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 |