FDA Adverse Event
Injury
Summary report: N
ELECTROTORQUE PLUS
MDR report key: 617448
·
Received June 24, 2005
Report
- Report Number
- 1419798-2005-00001
- Event Type
- Injury
- Date Received
- June 24, 2005
- Date of Event
- April 12, 2005
- Report Date
- April 13, 2005
- Manufacturer
- KAVO DENTAL
- Product Code
- EKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A DENTIST REPORTED THAT A PATIENT RECEIVED A SECOND DEGREE BURN ON THE INSIDE OF THEIR RIGHT CHEEK DURING THE USE OF A 25LPA HANDPIECE. IT WAS REPORTED THAT THE PT WENT TO A TREATMENT CENTER LATER THAT EVENING WHERE THEY WERE PRESCRIBED AMOXICILLIN; 250 MG, PO, CODEINE; 300 MG, PO AND AN UNKNOWN OINTMENT. FOLLOW UP WITH THE PT IN 2005 BY THE DENTIST REVEALED THAT THE PT HAS RECOVERED, WITH NO FURTHER CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROTORQUE PLUS | ELECTRIC DENTAL HANDPIECE | EKK | KAVO DENTAL | 25LPA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |