FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3820884
·
Received May 8, 2014
Report
- Report Number
- 1225714-2014-02245
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- June 1, 2011
- Report Date
- April 9, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED WITH MDR'S #1225714-2014-02245 AND 1225714-2014-02246.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED HEART PROBLEMS AND A METABOLIC ALKALOSIS EVENT ON (B)(6) 2011 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279237 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |