FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3980004
·
Received June 25, 2014
Report
- Report Number
- 1225714-2014-05288
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- March 23, 2012
- Report Date
- May 27, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR #2937457-2014-01291, 2937457-2014-01292, 1225714-2014-05288, 1225714-2014-05289, 1225714-2014-05290 AND 1225714-2014-05291.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR EVENTS ON OR ABOUT (B)(6) 2012 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370943 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |