FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5041791
·
Received August 27, 2015
Report
- Report Number
- 1225714-2015-06852
- Event Type
- Death
- Date Received
- August 27, 2015
- Date of Event
- May 19, 2006
- Report Date
- August 21, 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 PATIENT 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 THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED CARDIAC EVENT 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 |
|---|---|---|---|---|---|---|---|
| 567905 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |