FDA Adverse Event
Other
Summary report: N
MEDRAD ANGIOGRAPHIC INJECTOR
MDR report key: 272597
·
Received April 5, 2000
Report
- Report Number
- 2520313-2000-00002
- Event Type
- Other
- Date Received
- April 5, 2000
- Date of Event
- February 25, 2000
- Report Date
- April 4, 2000
- Manufacturer
- MEDRAD, INC.
- Product Code
- DXT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSPITAL REPORTED THEY HAD TWO INCIDENTS OF ANAPHYLATIC SHOCK. THE FIRST INCIDENT OCCURRED ON 2/25/00, THE SECOND ON 2/29/00. THE HOSP WAS DOING A REGULAR DIAGNOSTIC ANGIOGRAM, USING A MEDRAD MARK IV INJECTOR, 130 ML SYRINGE AND NON-IONIC ISOVUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDRAD ANGIOGRAPHIC INJECTOR | ANGIOGRAPHIC INJECTOR | DXT | MEDRAD, INC. | MKIV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |