FDA Adverse Event
Summary report: N
EDGE COATED ELECTRODE
MDR report key: 1945172
·
Received November 22, 2010
Report
- Report Number
- 1945172
- Date Received
- November 22, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 22, 2010
- Manufacturer
- COVIDIEN VALLEYLAB
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SUPERFICIAL BURN NOTED AT LEFT ORAL COMMISSURE AFTER PROCEDURE.======================HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN- NO SMOKE OR SPARK NOTED.======================MANUFACTURER RESPONSE FOR ELECTROSURGICAL HANDPIECE, INSULTATED COATED TIP AND PENCIL======================WE ASKED COVDIEN TO COME AND DISCUSS ELECTROSURGICAL EQUIPMENT USAGE. WE WANTED TO LOOK FOR QUALITY IMPROVEMENT OPPORTUNITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDGE COATED ELECTRODE | INSULATED COATED BLADE ELECTRODE | GEI | COVIDIEN VALLEYLAB | * | 189498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |