FDA Adverse Event
Injury
Summary report: N
132030-EMS GENERATOR SYSTEM 5000
MDR report key: 349141
·
Received August 23, 2001
Report
- Report Number
- 1213643-2001-00042
- Event Type
- Injury
- Date Received
- August 23, 2001
- Date of Event
- October 9, 1997
- Report Date
- August 23, 2001
- Manufacturer
- DAVOL, INC. (RI)
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PATIENT BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38476 | 132030-EMS GENERATOR SYSTEM 5000 | ELECTROSURGICAL GENERATOR | GEI | DAVOL, INC. (RI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |