FDA Adverse Event
Injury
Summary report: N
FRESENIUS 2008K
MDR report key: 4091409
·
Received August 28, 2014
Report
- Report Number
- 2937457-2014-02480
- Event Type
- Injury
- Date Received
- August 28, 2014
- Date of Event
- December 13, 2008
- Report Date
- August 18, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KDI
- PMA / PMN Number
- 994267
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT COLLAPSED AND EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2008 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2008 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523636 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |