FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4886445
·
Received July 1, 2015
Report
- Report Number
- 1225714-2015-04535
- Event Type
- Death
- Date Received
- July 1, 2015
- Date of Event
- July 21, 2012
- Report Date
- June 24, 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 FOR THIS EVENT. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED SUDDEN CARDIAC ARREST AND EXPIRED THE SAME DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 428556 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |