FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 3233782
·
Received July 16, 2013
Report
- Report Number
- 1225714-2013-01246
- Event Type
- Death
- Date Received
- July 16, 2013
- Date of Event
- June 8, 2011
- Report Date
- June 20, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR # 1225714-2013-01247.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011, AFTER THE USE OF THE PRODUCT. IN ADDITION, THE DECEDENT'S CERTIFICATE OF DEATH WAS RECEIVED INDICATING IMMEDIATE CAUSE OF DEATH TO BE CARDIAC ARREST AND UNDERLYING CAUSE WAS CORONARY ARTERY DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328520 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |