FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 4200884
·
Received October 22, 2014
Report
- Report Number
- 1225714-2014-13734
- Event Type
- Death
- Date Received
- October 22, 2014
- Date of Event
- March 6, 2011
- Report Date
- February 26, 2016
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS.
Additional Manufacturer Narrative · 1
THE ADDITIONAL INFORMATION RECEIVED ALLEGES THAT THE PATIENT EXPERIENCED THE EVENT APPROXIMATELY FIVE MONTHS PRIOR TO THE EVENT DATE THAT WAS INITIALLY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FURTHER CLARIFY THE EVENT DATE AND DETAILS SURROUNDING THE REPORTED EVENT; THIS INFORMATION WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-13733 AND 1225714-2014-13734.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2011 AFTER USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673834 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |