FDA Adverse Event
Death
Summary report: N
FRESENIUS 2008K
MDR report key: 3958231
·
Received July 16, 2014
Report
- Report Number
- 2937457-2014-01649
- Event Type
- Death
- Date Received
- July 16, 2014
- Date of Event
- March 18, 2011
- Report Date
- March 2, 2016
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERIC
- 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 THREE DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; THE ASSOCIATED MFR NUMBERS ARE 1225714-2014-06427, 1225714-2014-06428, AND 2937457-2014-01649. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2011 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 415953 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE NORTH AMERIC | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |