FDA Adverse Event
Other
Summary report: N
MICROCHOICE MEDIUM BUR GUARD
MDR report key: 841335
·
Received April 19, 2007
Report
- Report Number
- 1017294-2007-00205
- Event Type
- Other
- Date Received
- April 19, 2007
- Date of Event
- March 20, 2007
- Report Date
- March 20, 2007
- Manufacturer
- CONMED LINVATEC
- Product Code
- EQJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION RESULTS: THE BUR GUARD WAS RECEIVED FOR EVALUATION. THE INVESTIGATION OF THIS BUR GUARD FOUND THAT IT MET ALL TESTING SPECIFICATIONS. NO FAULT WAS FOUND WITH THIS DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS BUR GUARD WAS IN USE, A DRILL THAT OVERHEATED DURING ORAL SURGERY, RESULTING IN A BURN TO THE PATIENT'S LIP. ANTIBIOTIC OINTMENT AND A WET GAUZE WAS APPLIED TO TREAT THE AFFECTED AREA. TO DATE, IT IS UNKNOWN IF FURTHER TREATMENT IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROCHOICE MEDIUM BUR GUARD | BUR GUARD | EQJ | CONMED LINVATEC | NA | JAN07S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R | CATALOG NUMBER: 5020025L, MICROCHOICE HIGH SPEED| DRILL LOANER |