FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1364604
·
Received April 20, 2009
Report
- Report Number
- 1419798-2009-00009
- Event Type
- Injury
- Date Received
- April 20, 2009
- Date of Event
- March 9, 2009
- Report Date
- March 11, 2009
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WHILE THE DOCTOR WAS WORKING ON THE LEFT SIDE OF THE MOUTH, THE PATIENT RECEIVED A SMALL BURN TO THE CHEEK.
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 |