FDA Adverse Event
Injury
Summary report: N
FRESENIUS 2008K
MDR report key: 3810630
·
Received May 6, 2014
Report
- Report Number
- 2937457-2014-00768
- Event Type
- Injury
- Date Received
- May 6, 2014
- Date of Event
- December 14, 2012
- Report Date
- April 8, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KDI
- PMA / PMN Number
- 994267
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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; ASSOCIATED MDRS #1225714-2014-02181, 1225714-2014-02182, 1225714-2014-02183, 1225714-2014-02184, 2937457-2014-00768 AND 2937457-2014-00769.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 DURING THE USE OF THE PRODUCT. PATIENT WAS TRANSPORTED TO THE HOSPITAL. PATIENT EXPERIENCED ANOTHER CARDIOVASCULAR EVENT ON (B)(6) 2012 DURING USE OF THE PRODUCT AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271401 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE NORTH AMERICA | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |