FDA Adverse Event
Death
Summary report: N
FRESENIUS 2008K
MDR report key: 3980391
·
Received June 25, 2014
Report
- Report Number
- 2937457-2014-01297
- Event Type
- Death
- Date Received
- June 25, 2014
- Date of Event
- September 8, 2009
- Report Date
- May 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KDI
- PMA / PMN Number
- K994267
- 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 FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR # 2937457-2014-01297, 1225714-2014-05300 AND 1225714-2014-05301.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED SHORTNESS OF BREATH AND A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2009 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370676 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |