FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 5061548
·
Received September 4, 2015
Report
- Report Number
- 1225714-2015-07073
- Event Type
- Death
- Date Received
- September 4, 2015
- Date of Event
- September 6, 2012
- Report Date
- August 26, 2015
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K981043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT OF THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS. 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 A SUDDEN CARDIAC EVENT AND STROKE AND APPROXIMATELY TWO YEARS LATER EXPERIENCED ANOTHER SUDDEN CARDIAC EVENT AND EXPIRED ON THE SAME DAY. THE EVENT IS FURTHER ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTER DURING DIALYSIS TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589312 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| L |