FDA Adverse Event
Death
Summary report: N
GRANUFLO
MDR report key: 3820344
·
Received May 9, 2014
Report
- Report Number
- 1225714-2014-02423
- Event Type
- Death
- Date Received
- May 9, 2014
- Date of Event
- September 2, 2008
- Report Date
- May 4, 2016
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K030497
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; ASSOCIATED MANUFACTURER REPORT NUMBERS: 1225714-2014-02423 AND 1225714-2014-02424. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (DEATH) FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-02423 AND 1225714-2014-02424.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2008 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED CARDIOMYOPATHY ON THE PREVIOUSLY REPORTED DATE OF EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282272 | GRANUFLO | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |