FDA Adverse Event
Death
Summary report: N
AF-150
MDR report key: 437106
·
Received January 7, 2003
Report
- Report Number
- 1423500-2002-01669
- Event Type
- Death
- Date Received
- January 7, 2003
- Date of Event
- December 1, 2002
- Report Date
- December 11, 2002
- Manufacturer
- ALTHIN MEDICAL, AN AFFILIATE OF BHC
- Product Code
- KDI
- Removal / Correction Number
- 1423500-10/16/01-002-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
DEATH OF PT "AFTER RECEIVING DIALYSIS ON A DIALYZER CONTAINING A BAXTER FILTER". NO ADDITIONAL INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AF-150 | HOLLOW FIBER DIALYZER | KDI | ALTHIN MEDICAL, AN AFFILIATE OF BHC | AF-150 | NA01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |