FDA Adverse Event
Other
Summary report: N
CONMED / ASPEN SURGICAL
MDR report key: 439324
·
Received January 9, 2003
Report
- Report Number
- 439324
- Event Type
- Other
- Date Received
- January 9, 2003
- Date of Event
- December 24, 2002
- Report Date
- January 7, 2003
- Manufacturer
- CONMED CORP
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WAS IN FOR A BILATERAL TEMPORARY BX. PATIENT WAS DRAPED AS USUAL. WHEN ESU WAS TRIGGERED A FIRE BROKE OUT UNDER DRAPE. RESULT WAS A BURN TO PATIENT'S NECK, FACE, EAR AND UPPER CHEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED / ASPEN SURGICAL | ELECTROSURGICAL UNIT | GEI | CONMED CORP | 60-6250-001 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |