FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4898037
·
Received July 3, 2015
Report
- Report Number
- 1225714-2015-04681
- Event Type
- Death
- Date Received
- July 3, 2015
- Date of Event
- November 1, 2009
- Report Date
- June 23, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT FOR APPROXIMATELY 1 MONTH, THE PATIENT EXPERIENCED CARDIAC ARREST AND ALL INJURIES ASSOCIATED THEREWITH AND SUBSEQUENTLY EXPIRED. FURTHERMORE, IT WAS ALLEGED TO HAVE BEEN CAUSED BY EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433946 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |