FDA Adverse Event
Injury
Summary report: N
ELLMAN SURGITRON EMC
MDR report key: 297969
·
Received September 28, 2000
Report
- Report Number
- 2428235-2000-00005
- Event Type
- Injury
- Date Received
- September 28, 2000
- Date of Event
- August 12, 1999
- Report Date
- September 28, 2000
- Manufacturer
- ELLMAN INTERNATIONAL INC.
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PT ALLEGED TO HAVE SUFFERED BURNS TO MOUTH, THROAT, UVULA AND SOFT PALATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELLMAN SURGITRON EMC | RADIOSURGERY GENERATOR | GEI | ELLMAN INTERNATIONAL INC. | EMC | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | SOMOPLASTY MACHINE-08/12/1999| BOVIE. |