FDA Adverse Event
Other
Summary report: N
MED RAD
MDR report key: 751420
·
Received August 3, 2005
Report
- Report Number
- MW1036228
- Event Type
- Other
- Date Received
- August 3, 2005
- Date of Event
- June 28, 2005
- Report Date
- July 11, 2005
- Manufacturer
- MEDRAD
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
MED RAD INJECTOR FOUND NOT TO BE FUNCTIONING PROPERLY WHEN NEEDED TO BE INJECTING FOR LV GRAM. INJECTOR TAKEN OUT OF SERVICE, IMAGING ENGINEERS CALLED, COMPANY NOTIFIED. INJECTOR REPLACED WITH NEW INJECTOR. NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED RAD | INJECTOR | DXT | MEDRAD | MARK V PLUS | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |