FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3032488
·
Received March 29, 2013
Report
- Report Number
- 1225714-2013-00387
- Event Type
- Injury
- Date Received
- March 29, 2013
- Date of Event
- June 16, 2009
- Report Date
- March 5, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED AND ASSOCIATED WITH MDRS # 1225714-2013-00385, 1225714-2013-00386, 1225714-2013-00388.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2009 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2009 AFTER USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130179 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| L| O| R| S |