FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5109725
·
Received September 25, 2015
Report
- Report Number
- 1225714-2015-07527
- Event Type
- Death
- Date Received
- September 25, 2015
- Date of Event
- September 28, 2012
- Report Date
- September 17, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS EVENT IS ONE EVENT FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS.
Additional Manufacturer Narrative · 1
FURTHER ATTEMPTS TO OBTAIN COMPLAINT DETAILS WILL BE MADE AND UPON RECEIPT WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. RELATED MFR # 1225714-2015-07527 AND MFR # 1225714-2015-07528.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED AN ADVERSE CARDIAC EVENT AND SUBSEQUENTLY DIED, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED FOR DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636929 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |