FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 5009862
·
Received August 14, 2015
Report
- Report Number
- 1225714-2015-06417
- Event Type
- Death
- Date Received
- August 14, 2015
- Date of Event
- December 8, 2009
- Report Date
- August 11, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THE PATIENT (B)(4) IS BEING USED TO REPORT THE NON-SPECIFIC CARDIAC EVENT AS THERE IS NO CODE AVAILABLE TO CAPTURE THIS EVENT.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A 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 |
|---|---|---|---|---|---|---|---|
| 537943 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |