FDA Adverse Event
Other
Summary report: N
MEDRAD CT INJECTOR
MDR report key: 178300
·
Received July 20, 1998
Report
- Report Number
- 2520313-1998-00037
- Event Type
- Other
- Date Received
- July 20, 1998
- Date of Event
- June 16, 1998
- Report Date
- July 1, 1998
- Manufacturer
- MEDRAD, INC.
- Product Code
- DXT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSPITAL PERSONNEL REPORTED THAT DURING A CT PROCEDURE, AN EXTRAVASATION OCCURRED. IN ADDITION THE HOSPITAL REPORTED THAT THEY COULD NOT STOP THE INJECTOR BY PRESSING THE START SWITCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDRAD CT INJECTOR | CT INJECTOR | DXT | MEDRAD, INC. | MCT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |