FDA Adverse Event
Injury
Summary report: N
INTRAMATIC HANDPIECE 10CH
MDR report key: 1812352
·
Received August 16, 2010
Report
- Report Number
- 3003637274-2010-00022
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 19, 2010
- Manufacturer
- KAVO DENTAL GMBH
- Product Code
- EFB
- PMA / PMN Number
- K073478
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING REMOVING OF ALL 4 WISDOM TEETH, THE PATIENT WAS BURNED ON THE LOWER RIGHT AND LEFT LIP. THE PATIENT WAS GIVEN OINTMENT AND ANTIBIOTIC. DURING PRODUCT EVALUATION, MEDIUM DEBRIS LEVELS WERE FOUND IN THE HANDPIECE. THE BEARINGS FALLING APART AND THE CHUCK WOBBLES. THE CAUSE FOR OVERHEATING WHERE THE WORN BEARINGS, WHICH LEAD TO HEAT UP THE HANDPIECE.
Description of Event or Problem · 1
A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PATIENT USING A DENTAL ELECTRIC HANDPIECE WHEN THE PATIENT LOWER RIGHT AND LEFT LIP WAS BURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRAMATIC HANDPIECE 10CH | DENTAL HANDPIECE | EFB | KAVO DENTAL GMBH | 10CH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |