FDA Adverse Event
Injury
Summary report: N
ASPEN SURGICAL SYSTEMS
MDR report key: 81962
·
Received April 4, 1997
Report
- Report Number
- 1720159-1997-00011
- Event Type
- Injury
- Date Received
- April 4, 1997
- Date of Event
- March 5, 1997
- Manufacturer
- ASPEN LABORATORIES, INC.
- Product Code
- GEI
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASPEN SURGICAL SYSTEMS | ELECTROSURGICAL PENCIL | GEI | ASPEN LABORATORIES, INC. | HAND-TROL | 96KHA003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MAFR: CONMED UTICA| EXTENDED ELECTRODE, CAT # 138020 |