FDA Adverse Event
Injury
Summary report: N
FRESENIUS 2008K
MDR report key: 3936033
·
Received June 23, 2014
Report
- Report Number
- 2937457-2014-01181
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- August 15, 2010
- Report Date
- May 23, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE
- Product Code
- KDI
- PMA / PMN Number
- 994267
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO EVENTS (CARDIOVASCULAR) FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-05076, 1225714-2014-05077, 1225714-2014-05078, 1225714-2014-05079, 2937457-2014-01181 AND 2937457-2014-01182.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2010 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2010, AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367126 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |