FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1673161
·
Received April 29, 2010
Report
- Report Number
- 1017522-2010-00004
- Event Type
- Injury
- Date Received
- April 29, 2010
- Date of Event
- March 30, 2010
- Report Date
- April 2, 2010
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- EKX
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- VA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A DENTIST WAS PERFORMING A ROUTINE PROCEDURE, ON A PT USING A DENTAL ELECTRIC HANDPIECE WHEN THE PT'S TONGUE WAS BURNED BY THE HEAD OF THE HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPA | DENTAL HANDPIECE | EKX | KAVO DENTAL GMBH | 25LPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |