FDA Adverse Event
Other
Summary report: N
NONE
MDR report key: 3123640
·
Received May 15, 2013
Report
- Report Number
- 3003637274-2013-00013
- Event Type
- Other
- Date Received
- May 15, 2013
- Product Code
- EFB
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
DURING A STANDARD DENTAL TREATMENT, THE HANDPIECE HEATED UP AND BURNED THE PATIENT ON LOWER LIP. THE BURN WAS SMALLER THAN A DIME. NO OINTMENT OR MEDICATION WAS PRESCRIBED OR GIVEN TO PATIENT. TWO PERSONS HAVE BEEN BURNED WITH THIS HANDPIECE ON THE SAME DAY. SEE ALSO MDR 3003637274-2013-00012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215109 | NONE | EFB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |