FDA Adverse Event
Injury
Summary report: N
CONMED CORPORATION
MDR report key: 218290
·
Received April 8, 1999
Report
- Report Number
- 1720159-1999-00016
- Event Type
- Injury
- Date Received
- April 8, 1999
- Date of Event
- March 8, 1999
- Report Date
- March 11, 1999
- Manufacturer
- ASPEN LABORATORIES, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PROCEDURE WAS AN AORTIC ANEURYSM. THERE WAS A BURN ON THE DORSAL SIDE. THE INJURY WAS HEALED IN 3 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED CORPORATION | ELECTROSURGICAL UNIT | GEI | ASPEN LABORATORIES, INC. | EXCALIBUR PLUS PC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |