FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4994979
·
Received August 10, 2015
Report
- Report Number
- 1225714-2015-06087
- Event Type
- Death
- Date Received
- August 10, 2015
- Date of Event
- November 19, 2009
- Report Date
- July 29, 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 EVENT FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS. ADD'L INFO HAS BEEN REQUESTED & WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTY ALLEGED THAT THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST 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 |
|---|---|---|---|---|---|---|---|
| 522378 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |