FDA Adverse Event
Death
Summary report: N
NATURALYTE
MDR report key: 3861826
·
Received May 28, 2014
Report
- Report Number
- 1225714-2014-03521
- Event Type
- Death
- Date Received
- May 28, 2014
- Date of Event
- October 6, 2007
- Report Date
- April 29, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR #1225714-2014-03520 AND 1225714-2014-03521.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED HYPOXIA ON OR ABOUT (B)(6) 2007 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314705 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |