FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 2850885
·
Received November 15, 2012
Report
- Report Number
- 1225714-2012-00006
- Event Type
- Death
- Date Received
- November 15, 2012
- Date of Event
- August 27, 2010
- Report Date
- October 16, 2012
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPIRED AFTER THE USE OF THE PRODUCT ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Death |