FDA Adverse Event
Other
Summary report: N
THERASPHERE
MDR report key: 2434674
·
Received January 26, 2012
Report
- Report Number
- 8022247-2012-00003
- Event Type
- Other
- Date Received
- January 26, 2012
- Date of Event
- January 6, 2012
- Report Date
- January 25, 2012
- Manufacturer
- NORDION (CANADA) INC.
- Product Code
- NAW
- PMA / PMN Number
- H980006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE PT PRESENTED TO THE ER ON (B)(6) 2012, COMPLAINING OF SEVERE ABDOMINAL PAIN, NAUSEA AND VOMITING. THE UPPER GI ENDOSCOPY SHOWED "ULCERATION AND DUSKY DISCOLORATION" OF THE LESSER CURVATURE OF THE STOMACH, AND SUSPECTED TO BE ISCHEMIA MOST LIKELY DUE TO RECENT THERASPHERE TREATMENT(S). HE HAD HIS FIRST TREATMENT (B)(6) 2011 (RIGHT LOBE), AND THE SECOND TREATMENT (B)(6) 2011 (LEFT SEGMENT 4A AND 4B). HIS GASTRIC ARTERIES WERE NOT PROPHYLACTICALLY EMBOLIZED DUE TO THE SEGMENTAL TREATMENT PLAN AND THE NORMAL MAA SCAN.
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 | Hospitalization |