FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 4995012
·
Received August 10, 2015
Report
- Report Number
- 1225714-2015-06107
- Event Type
- Death
- Date Received
- August 10, 2015
- Date of Event
- December 8, 2006
- Report Date
- July 31, 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 PT INVOLVING TWO SEPARATE PRODUCTS. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THE (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 PT EXPERIENCED 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 |
|---|---|---|---|---|---|---|---|
| 522429 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |