FDA Adverse Event
Death
Summary report: N
CELL-PRO
MDR report key: 242520
·
Received August 26, 1999
Report
- Report Number
- 242520
- Event Type
- Death
- Date Received
- August 26, 1999
- Date of Event
- August 16, 1999
- Report Date
- August 19, 1999
- Manufacturer
- NEXELL THERAPEUTICS, INC.
- Product Code
- GKT
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE PT WAS FOUND DEAD IN HIS BED EARLY ON THE MORNING OF 8/16/99. THE DEATH WAS NOT WITNESSED AND THE FAMILY REFUSED TO ALLOW AN AUTOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CELL-PRO | CELL SELECTION COLUMN | GKT | NEXELL THERAPEUTICS, INC. | PRECOLUMN, AVIDIN COLUMN | 208L01, 204L03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death |