FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5032438
·
Received August 25, 2015
Report
- Report Number
- 1225714-2015-06704
- Event Type
- Death
- Date Received
- August 25, 2015
- Date of Event
- February 19, 2011
- Report Date
- August 17, 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
THE PATIENT CODE (B)(4) IS USED TO DESCRIBE THE NON-UNSPECIFIC CARDIAC EVENT, AS THERE IS NO OTHER CODE THAT BEST FITS CARDIAC EVENT. THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THE SAME EVENT. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTY ALLEGED THAT THE PATIENT EXPERIENCED A 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 |
|---|---|---|---|---|---|---|---|
| 560539 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |