FDA Adverse Event
Injury
Summary report: N
MOBILE C-ARM SERIES 9800
MDR report key: 306967
·
Received November 28, 2000
Report
- Report Number
- 1720753-2000-00008
- Event Type
- Injury
- Date Received
- November 28, 2000
- Date of Event
- November 1, 2000
- Report Date
- November 28, 2000
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING INITIAL FLUOROSCOPIC IMAGING NEEDED FOR A LUMBAR EPIDURAL STEROID INJECTION THE DR REPORTED THAT HE COULD NOT OBTAIN A CLEAR IMAGE OF THE AFFECTED AREA. DR ELECTED TO CONTINUE THE PROCEDURE WITHOUT FURTHER IMAGING. IT WAS SUBSEQUENTLY REPORTED TO OEC THAT THE PT WAS LATER ADMITTED TO HOSP FOR UNKNOWN REASONS. OEC HAS ATTEMPTED TO CONTACT THE PHYSICIAN FOR MORE SPECIFIC INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILE C-ARM SERIES 9800 | MOBILE FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM | JAA | GE OEC MEDICAL SYSTEMS, INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |