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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO KPO

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FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO KPO Back to Search Results
Device Problem Insufficient Information
Event Date 02/01/2008
Event Type  Death  
Event Description

The plaintiff's attorney alleged that the decedent experienced a sudden cardiac event on or about (b)(6) 2008 and subsequently expired on (b)(6) 2008, after the use of the product.

 
Manufacturer Narrative

This is one event for the same patient involving two separate products.

 
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Brand NameGRANUFLO
Type of DeviceKPO
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA
Manufacturer Contact
corie vazquez
920 winter street
waltham , MA 02451
7816999071
MDR Report Key4593434
Report Number1225714-2015-01053
Device Sequence Number1
Product CodeKPO
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 02/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2015
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 Received02/23/2015
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: 03/11/2015 Patient Sequence Number: 1
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