FDA Adverse Event
Injury
Summary report: N
NATURAYLE
MDR report key: 3821314
·
Received May 9, 2014
Report
- Report Number
- 1225714-2014-02402
- Event Type
- Injury
- Date Received
- May 9, 2014
- Date of Event
- January 15, 2010
- Report Date
- April 11, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF THREE EVENTS REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS MDRS# 1225714-2014-02401, 1225714-2014-02402, 1225714-2014-02403, 1225714-2014-02404, 1225714-2014-02405 AND 1225714-2014-02406.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR EVENTS ON (B)(6) 2010, ON (B)(6) 2010, AND ON (B)(6) 2010 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282267 | NATURAYLE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |