FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 3845074
·
Received May 20, 2014
Report
- Report Number
- 1225714-2014-03117
- Event Type
- Death
- Date Received
- May 20, 2014
- Date of Event
- March 25, 2010
- Report Date
- April 23, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) OF THREE EVENTS REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED MDRS # 1225714-2014-03112, 1225714-2014-03113, 1225714-2014-03114, 1225714-2014-03115, 1225714-2014-03116, AND 1225714-2014-03117.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2000 AND (B)(6) 2008 AND SUBSEQUENTLY EXPIRED ON (B)(6 )2010, AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298896 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |