FDA Adverse Event
Death
Summary report: N
FRESENIUS 2008K
MDR report key: 3954582
·
Received July 17, 2014
Report
- Report Number
- 2937457-2014-01694
- Event Type
- Death
- Date Received
- July 17, 2014
- Date of Event
- November 1, 2006
- Report Date
- March 8, 2016
- 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
(B)(4). THE ADDITIONAL INFORMATION NOTED THAT THE PATIENT EXPIRED, BUT IT DID NOT SPECIFICALLY STATE A DATE OF DEATH. THIS IS ONE OF THREE DEVICE REPORTS RELATED TO THIS EVENT. MANUFACTURER REPORT NUMBERS ARE 1225714-2014-06499, 1225714-2014-06500 AND 2937457-2014-01694. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS.
Description of Event or Problem · 1
THE ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2006 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420395 | FRESENIUS 2008K | KDI | FRESENIUS MEDICAL CARE | 2008K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| L| O| R| S |