FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3060178
·
Received April 11, 2013
Report
- Report Number
- 1225714-2013-00535
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- January 1, 2010
- Report Date
- March 14, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT REPRESENTS MULTIPLE EVENTS REPORTED (CARDIOVASCULAR AND CEREBROVASCULAR) FOR THE YEAR 2010 AND ASSOCIATED WITH MDR #S 1225714-2013-00536, 00537, 00538, 00539, 00540, 00541, 00542.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN 2010, 2011 AND 2012; SUBSEQUENTLY, EXPIRING ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156134 | GRANUFLO | DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| O| R| S |