FDA Adverse Event
Injury
Summary report: N
COMMED
MDR report key: 328244
·
Received April 13, 2001
Report
- Report Number
- 328244
- Event Type
- Injury
- Date Received
- April 13, 2001
- Date of Event
- April 5, 2001
- Report Date
- April 13, 2001
- Manufacturer
- CONMED CORP
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
A 1/4 INCH IN DIAMETER BURN WAS NOTED UNDER THE BOVIE PAD AFTER THE CASE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17019 | COMMED | DUAL DISPERSIVE ELECTRODE | GEI | CONMED CORP | SURE FIT | 0101291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |