FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 3441693
·
Received October 30, 2013
Report
- Report Number
- 1225714-2013-03303
- Event Type
- Injury
- Date Received
- October 30, 2013
- Date of Event
- September 29, 2011
- Report Date
- October 21, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR # 2937457-2013-00328, 00329, 03300, 03301, 03302.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OAR ABOUT (B)(6) 2011 AND THEREAFTER , EXPERIENCED ANOTHER CARDIOVASCULAR EVENT SUBSEQUENTLY EXPIRED ON (B)(6) 2011, AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557283 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |