FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 3861759
·
Received May 28, 2014
Report
- Report Number
- 1225714-2014-03548
- Event Type
- Death
- Date Received
- May 28, 2014
- Date of Event
- October 5, 2012
- Report Date
- April 29, 2014
- 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
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR #S 1225714-2014-03546, 03547, 03548 AND 03549.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314674 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |