FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3934525
·
Received June 27, 2014
Report
- Report Number
- 1225714-2014-05350
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- November 3, 2003
- 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 THREE EVENTS FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-05348; 05349; 05350; 05351; 05352; 05353; 2937457-2014-01340; 01341; 01342
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2003, A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2003, AND CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2003 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376000 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |