FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1364605
·
Received April 20, 2009
Report
- Report Number
- 8010493-2009-00009
- 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
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PATIENT WAS GIVEN OINTMENT FOR TREATMENT OF BURN. DURING THE HANDPIECE EVALUATION, IT WAS FOUND THAT THE BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY, SHAFT AND AXLE, THE WATER FACE PLATE WAS DENTED, THE HEAD WAS DENTED AFFECTING OPERATION, AND MEDIUM DEBRIS WAS PRESENT.
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 |