FDA Adverse Event Death Summary report: N

NATURALYTE

MDR report key: 2982280 · Received February 25, 2013

Report

Report Number
1225714-2013-00164
Event Type
Death
Date Received
February 25, 2013
Date of Event
July 23, 2010
Report Date
January 27, 2013
Manufacturer
FRESENIUS MEDICAL CARE NORTH AMERICA
Product Code
KPO
PMA / PMN Number
K070177
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPIRED ON (B)(6) 2010 AFTER THE USE OF THE PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
78974 NATURALYTE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

Patients

Seq Age Sex Outcome Treatment
1 23 YR Death