FDA Adverse Event
Injury
Summary report: N
TIMAX
MDR report key: 2163473
·
Received June 20, 2011
Report
- Report Number
- 1032227-2011-00002
- Event Type
- Injury
- Date Received
- June 20, 2011
- Report Date
- May 19, 2011
- Manufacturer
- NSK TOCHIGI-KEN
- Product Code
- EGS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CT, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE DENTIST ADVISED THAT DURING A CROWN PROCEDURE, THE RIGHT SIDE OF THE PATIENT'S TONGUE WAS SEVERELY BURNED. THE DENTIST REMOVED THE DEAD SKIN AND GAVE THE PATIENT OINTMENT. THE DENTIST ADVISED HE BELIEVED THERE WOULD BE SOME SCARRING ON THE TONGUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIMAX | EGS | NSK TOCHIGI-KEN | TI95L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |