FDA Adverse Event
Injury
Summary report: N
GRANUFLO
MDR report key: 3080025
·
Received April 24, 2013
Report
- Report Number
- 1225714-2013-00651
- Event Type
- Injury
- Date Received
- April 24, 2013
- Date of Event
- July 23, 2007
- Report Date
- March 27, 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 ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDRS # 1225714-2013-00652, 1225714-2013-00653, 1225714-2013-00654.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AFTER USE OF THE PRODUCT ON (B)(6) 2007 AND WAS RESUSCITATED. HE EXPERIENCED A SECOND CARDIOVASCULAR EVENT AFTER USE OF THE PRODUCT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177508 | GRANUFLO | DRY ACID CONCENTRATE FOR BIOCARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| L| O| R| S |