FDA Adverse Event
Other
Summary report: N
STELLANT DUAL INJECTOR
MDR report key: 1674479
·
Received April 29, 2010
Report
- Report Number
- 2520313-2010-00016
- Event Type
- Other
- Date Received
- April 29, 2010
- Date of Event
- March 31, 2010
- Report Date
- April 29, 2010
- Manufacturer
- MEDRAD, INC.
- Product Code
- DXT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A CHECK OUT OF THE INJECTOR BY MEDRAD SERVICE WAS PERFORMED. THE SYSTEM CHECKED OUT ACCORDING TO SPECIFICATIONS. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED TO THE CUSTOMER, BUT THEY INDICATED THAT APPLICATIONS TRAINING WAS NOT NEEDED. NO PRODUCT RETURNING.
Description of Event or Problem · 1
THE HOSPITAL REPORTED DURING A CTA RUNOFF PROCEDURE, 150 MLS OF FLUID EXTRAVASATED INTO THE PT'S RIGHT ANTECUBITAL AREA. THE PT WAS ADMITTED FOR A 2 DAY OBSERVATION. DURING ADMISSION THE PT WAS CONSULTED BY PLASTIC SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLANT DUAL INJECTOR | STELLANT DUAL INJECTOR | DXT | MEDRAD, INC. | 3010432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |