FDA Adverse Event
Injury
Summary report: N
GENTLEPOWER LUX CONTRA ANGLE 25LPA
MDR report key: 1200664
·
Received October 20, 2008
Report
- Report Number
- 8010493-2008-00019
- Event Type
- Injury
- Date Received
- October 20, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 22, 2008
- 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
THE PATIENT WAS GIVEN KENALOG ORABASE IN THE OFFICE AND TOLD TO FOLLOW-UP WITH NEOSPORIN AT HOME. THE DOCTOR STATED THAT THE PATIENT HEALED FINE. THERE WAS A DENT AT 11 IN THE HEAD, AND THE DRIVE AND CHUCK WERE BAD. THE DEBRIS LEVEL PASSED. UPON EVALUATION OF THE HANDPIECE THE DOCTOR WAS INFORMED THAT THE DENT IN THE HEAD WAS THE CAUSE OF THE OVERHEATING. A TWO YEAR SERVICE CHECK WAS SUGGESTED FOR PROPER MAINTENANCE.
Description of Event or Problem · 1
WHILE THE DENTIST WAS WORKING ON TOOTH #31, THE LOWER LIP OF THE PATIENT WAS BURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENTLEPOWER LUX CONTRA ANGLE 25LPA | DENTAL HANDPIECES AND ACCESSORIES | EFB | KALTENBACH & VOIGT GMBH | 25LPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |