FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 3082208
·
Received April 25, 2013
Report
- Report Number
- 1225714-2013-00677
- Event Type
- Death
- Date Received
- April 25, 2013
- Date of Event
- March 25, 2012
- Report Date
- March 28, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTED EVENT IS ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR # 1225714-2013-00678.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178116 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |