FDA Adverse Event
Other
Summary report: N
HALL SURGICAL BUR GUARD, MEDIUM
MDR report key: 1213726
·
Received October 23, 2008
Report
- Report Number
- 1017294-2008-00334
- Event Type
- Other
- Date Received
- October 23, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- CONMED LINVATEC
- Product Code
- EQJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS LOANER BUR GUARD FOR EVALUATION. DURING TESTING OF THE BUR GUARD, THE REPORTED PROBLEM OF OVERHEATING WAS UNABLE TO BE DUPLICATED, AS THE DEVICE OPERATED TO MANUFACTURER TEMPERATURE SPECIFICATION. FURTHER INVESTIGATION FOUND THIS UNIT WITHIN THE PREVENTIVE MAINTENANCE SCHEDULE; LAST SERVICED 2008. ASSOCIATED MDR#: 1017294-2008-00333.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING USE OF THIS LOANER BUR GUARD WITH HANDPIECE TO PERFORM A THIRD MOLAR EXTRACTION, THE PT RECEIVED A BURN TO THE RIGHT LOWER LIP. THE AFFECTED AREA WAS TREATED WITH NEOSPORIN OINTMENT. THE CUSTOMER REPORTED THAT NO RESIDUAL AFFECTS RESULTED FROM THIS EVENT, AS NOTED ON THE PT'S FOLLOW-UP APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HALL SURGICAL BUR GUARD, MEDIUM | BUR GUARD | EQJ | CONMED LINVATEC | NA | JUN08S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NK | Required Intervention | SURGAIRTOME TWO HANDPIECE |