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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS

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FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS Back to Search Results
Device Problem Insufficient Information
Event Date 06/10/2007
Event Type  Death  
Event Description

Concentrate (dry) -- e6. The plaintiff's attorney alleged that the decedent experienced a cardiovascular event and subsequently expired on/about (b)(6) 2007 after the use of the product.

 
Manufacturer Narrative

This is one event (death) for the same patient involving two separate products; associated mdr # 1225714-2013-00796.

 
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Brand NameNATURALYTE
Type of DeviceDRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham , MA 02451-1457
7816999000
MDR Report Key3095817
Report Number1225714-2013-00797
Device Sequence Number1
Product CodeKPO
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/02/2013 Patient Sequence Number: 1
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