FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 3810635
·
Received May 6, 2014
Report
- Report Number
- 1225714-2014-02186
- Event Type
- Injury
- Date Received
- May 6, 2014
- Date of Event
- February 1, 2010
- Report Date
- April 8, 2014
- 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 (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-02185, 1225714-2014-02186, 1225714-2014-02187, 1225714-2014-02188, 2937457-2014-00770 AND 2937457-2014-00771.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED CARDIOVASCULAR EVENTS ON TWO DIFFERENT DATES IN (B)(6) 2010 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271179 | NATURALYTE | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |