FDA Adverse Event
Other
Summary report: N
THERASPHERE
MDR report key: 2484801
·
Received March 6, 2012
Report
- Report Number
- 8022247-2012-00005
- Event Type
- Other
- Date Received
- March 6, 2012
- Date of Event
- September 15, 2011
- Report Date
- March 2, 2012
- Manufacturer
- NORDION (CANADA) INC.
- Product Code
- NAW
- PMA / PMN Number
- H980006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE PATIENT HAD Y-90 RADIOEMBOLIZATION ON (B)(6) 2011. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AT (B)(6) HOSPITAL VOMITING BLOOD AND WITH A GI BLEED AND WAS ADMITTED FOR CARE AND GI CONSULT. ABDOMINAL CT SCAN WAS PERFORMED ON (B)(6) 2011, WITH A REPORT OF HYPERDENSE MATERIAL IN THE STOMACH OR LIKELY A SMALL BLEED. THE PATIENT IS PART OF AN IIS FOR THERASPHERE AND SORAFENIB BEING PERFORMED AT (B)(6) UNIVERSITY AND (B)(6) HOSPITAL AND HAS BEEN TAKING SORAFENIB SINCE (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERASPHERE | YTTRIUM-90 MICROSPHERES | NAW | NORDION (CANADA) INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization |