FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5067070
·
Received September 8, 2015
Report
- Report Number
- 1225714-2015-07172
- Event Type
- Death
- Date Received
- September 8, 2015
- Date of Event
- April 8, 2008
- Report Date
- August 27, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THE SAME EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND SUBSEQUENTLY EXPIRED, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591177 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |