FDA Adverse Event
Other
Summary report: N
CT9000 ADV UC/MOB
MDR report key: 782134
·
Received November 15, 2006
Report
- Report Number
- 1518293-2006-00023
- Event Type
- Other
- Date Received
- November 15, 2006
- Date of Event
- October 17, 2006
- Report Date
- November 3, 2006
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- DXT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTED AND VERIFIED THAT INJECTOR IS OPERATING WITHIN FACTORY SPECIFICATION.
Description of Event or Problem · 1
LF FSE REPORTS VIA FAX THAT CUSTOMER REPORTS ALLEGED AIR INJECTION. CUSTOMER REPORTS MALE HAVING CT OF CHEST FOR POSSIBLE PE. AIR WAS NOTED AT THE END OF THE CT SCAN. CUSTOMER FEELS THAT APPROXIMATELY 100ML OF AIR WAS INJECTED. THREE DAYS LATER, RISK MANAGEMENT HAS REPLIED THAT NO FURTHER INFORMATION WILL BE MADE AVAILABLE. WHEN CUSTOMER PROVIDES ADDITIONAL INFORMATION PERTAINING TO THIS ALLEGED EVENT, THAT WILL BE SUBMITTED TO THE FDA ON A SUPPLEMENTAL FOLLOW UP REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CT9000 ADV UC/MOB | ANGIOGRAPHIC POWER INJECTOR SYSTEM | DXT | LIEBEL-FLARSHEIM CO. | CT9000ADV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |