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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 01/01/2010
Event Type  Injury  
Event Description

The plaintiff's attorney alleged that in or around early 2010, decedent experienced two (2) separate cardiovascular events on two (2) separate occasions and subsequently expired after use of the product.

 
Manufacturer Narrative

This report represents one event of three and is associated with mdrs #1225714-2013-00325, 00326, 00327, 00329, 00330.

 
Manufacturer Narrative

This report represents one of three events and is associated with the following manufacturer report numbers: 1225714-2013-00325, 1225714-2013-00326, 1225714-2013-00327, 1225714-2013-00328, 1225714-2013-00329, and 1225714-2013-00330.

 
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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 (Section G)
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham , MA 02451-1457
7816999000
MDR Report Key3027724
Report Number1225714-2013-00328
Device Sequence Number1
Product CodeKPO
Report Source Manufacturer
Source Type Other,Consumer,CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 02/28/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2013
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2013
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: 03/27/2013 Patient Sequence Number: 1
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