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