FDA Adverse Event
Injury
Summary report: N
ASPEN SURGICAL SYSTEMS
MDR report key: 273908
·
Received April 14, 2000
Report
- Report Number
- 1720159-2000-00035
- Event Type
- Injury
- Date Received
- April 14, 2000
- Date of Event
- March 2, 2000
- Report Date
- March 17, 2000
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASPEN SURGICAL SYSTEMS | ELECTROSURGICAL PENCIL | GEI | HAND-TROL | 99KHA007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |