FDA Adverse Event
Injury
Summary report: N
INTRAMATIC LUX3 CONTRA ANGLE 25LHA
MDR report key: 1349204
·
Received March 24, 2009
Report
- Report Number
- 8010493-2009-00003
- Event Type
- Injury
- Date Received
- March 24, 2009
- Report Date
- January 13, 2009
- Manufacturer
- KALTENBACH & VOIGT GMBH
- Product Code
- EFB
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT FOLLOWED UP WITH FAMILY PHYSICIAN FOR TREATMENT OF BURN. BEARINGS WERE WORN & GRITTY IN DRIVE ASSEMBLY, SHAFT, AXLE & SPUR WHEEL, THE BEARINGS WERE FALLING APART, THE WATER/CHIP AIR/FILTER LINE WAS CLOGGED, THE CHUCK SLIPS, AND DEBRIS LEVEL OF THE HANDPIECE WAS HIGH. THE 25LHA HANDPIECE WAS REPLACED WITH A NEW 25LPA HANDPIECE.
Description of Event or Problem · 1
WHILE THE DOCTOR WAS WORKING ON A COMPOSIT FILLING, THE HANDPIECE MADE A LOUD NOISE AND STOPPED WORKING. WHEN THE DOCTOR REMOVED THE HANDPIECE FROM THE PATIENT'S MOUTH, IT WAS HOT, AND CAUSED A BURN TO THE PATIENT'S LIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRAMATIC LUX3 CONTRA ANGLE 25LHA | DENTAL HANDPIECE AND ACCESSORIES | EFB | KALTENBACH & VOIGT GMBH | 25LHA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |