FDA Adverse Event
Death
Summary report: N
THERASPHERE
MDR report key: 2016362
·
Received March 11, 2011
Report
- Report Number
- 8022247-2011-00002
- Event Type
- Death
- Date Received
- March 11, 2011
- Date of Event
- January 30, 2011
- Report Date
- March 11, 2011
- Manufacturer
- NORDION (CANADA) INC.
- Product Code
- NAW
- PMA / PMN Number
- HDE H980006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EXPLANTATION NOT POSSIBLE.
Description of Event or Problem · 1
A PATIENT ENROLLED IN AN INVESTIGATOR INITIATED STUDY DIED APPROXIMATELY 6 WEEKS FOLLOWING THERASPHERE TREATMENT OF CAUSES YET TO BE DETERMINED. DUE TO THE TIME PERIOD AND LACK OF INFORMATION ON THE CAUSE OF DEATH THE PRINCIPAL INVESTIGATOR COULD NOT ELIMINATE THE RELATIONSHIP WITH THERASPHERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERASPHERE | YTTRIUM-90 GLASS MICROSPHERES | NAW | NORDION (CANADA) INC. | 0990134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Death |