FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 3945937
·
Received June 19, 2014
Report
- Report Number
- 1225714-2014-05005
- Event Type
- Death
- Date Received
- June 19, 2014
- Date of Event
- August 8, 2010
- Report Date
- May 23, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS: ASSOCIATED MDRS # 1225714-2014-05002; 05003; 05004; 05005; 2937457-2014-01146 AND 01147.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR EVENTS ON OR ABOUT (B)(6) 2010 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2010 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360304 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |