FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5003192
·
Received August 12, 2015
Report
- Report Number
- 1225714-2015-06305
- Event Type
- Death
- Date Received
- August 12, 2015
- Date of Event
- January 26, 2010
- Report Date
- August 7, 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
THE PT CODE (B)(4) WAS USED TO REPORT THE NON-SPECIFIC CARDIAC EVENT FOR WHICH THERE IS NO CODE AVAILABLE. THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THE SAME EVENT. ADDITIONAL 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 A CARDIAC EVENT AND SUBSEQUENTLY EXPIRED, 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 |
|---|---|---|---|---|---|---|---|
| 528668 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |