FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3030283
·
Received March 28, 2013
Report
- Report Number
- 1225714-2013-00369
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- July 1, 2011
- Report Date
- March 1, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030491
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH REPORT IS ASSOCIATED WITH MDR# 1225714-2013-00370.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT IN OR ABOUT (B)(6) 2011 AFTER USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128648 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| L| O| R| S |