FDA Adverse Event
Injury
Summary report: N
NATURALYTE
MDR report key: 3093783
·
Received April 30, 2013
Report
- Report Number
- 1225714-2013-00749
- Event Type
- Injury
- Date Received
- April 30, 2013
- Date of Event
- July 3, 2012
- Report Date
- April 2, 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 REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR # 1225714-2013-000748.
Additional Manufacturer Narrative · 1
THIS REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR # 1225714-2013-000748.
Description of Event or Problem · 1
THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186841 | NATURALYTE | DRY ACID CONCENTRATE FOR BIOCARBONATE DIALYSIS | KPO | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R| S |