FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1361984
·
Received April 15, 2009
Report
- Report Number
- 8010493-2009-00008
- Event Type
- Injury
- Date Received
- April 15, 2009
- Date of Event
- March 18, 2009
- Report Date
- March 18, 2009
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PATIENT WAS PRESCRIBED 600MG IBUPROFEN AND 20% BENZOCAINE GEL. PATIENT WAS ALSO ADVISED TO RINSE WITH WARM SALT WATER. PATIENT HAS COMPLETELY HEALED. DURING THE HANDPIECE EVALUATION, IT WAS FOUND THAT THE BEARINGS WERE WORN, AND GRITTY IN THE DRIVE ASSEMBLY, SHAFT AND AXLE, THE HEAD WAS DENTED, AND MEDIUM DEBRIS WAS PRESENT.
Description of Event or Problem · 1
WHILE THE DOCTOR WAS WORKING ON TOOTH #3, THE PATIENT'S CHEEK WAS BURNED 10MM BY 5MM.
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 |