FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 3934965
·
Received June 23, 2014
Report
- Report Number
- 1225714-2014-05099
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- June 12, 2008
- Report Date
- May 23, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- KPO
- PMA / PMN Number
- K070177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #2937457-2014-01192, 2937457-2014-01193, 1225714-2014-05098, 1225714-2014-05099, 1225714-2014-05100 AND 1225714-2014-05101.
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 ON (B)(6) 2008 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364631 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |