FDA Adverse Event
Death
Summary report: N
MEDRAD MR INJECTOR
MDR report key: 818968
·
Received February 15, 2007
Report
- Report Number
- 2520313-2007-00005
- Event Type
- Death
- Date Received
- February 15, 2007
- Date of Event
- January 8, 2007
- Report Date
- February 15, 2007
- Manufacturer
- MEDRAD, INC.
- Product Code
- DXT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HOSPITAL INDICATED THAT THE INCIDENT OCCURRED DUE TO ADVERSE REACTION TO CONTRAST MEDIUM. INJECTOR WAS CHECKED AS PART OF MEDRAD'S STANDARD PRACTIVE. MEDRAD SERVICE REPRESENTATIVE CHECKED INJECTOR WITH NO PROBLEMS FOUND WITH THE UNIT.
Description of Event or Problem · 1
HOSPITAL REPORTED SHORTLY AFTER FINISHING MRI OF RENALS USING PROHANCE CONTRAST MEDIUM, THE PATIENT INDICATED HE COULD NOT BREATHE AND WENT INTO CARDIAC ARREST. CPR WAS ATTEMPTED, BUT THE PATIENT EXPIRED. HOSPITAL INDICATED THIS INCIDENT OCCURRED DUE TO AN ADVERSE REACTION TO THE PROHANCE CONTRAST MEDIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDRAD MR INJECTOR | MR INJECTOR | DXT | MEDRAD, INC. | SMR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |