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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CAR NORTH AMERICA GRANUFLO

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FRESENIUS MEDICAL CAR NORTH AMERICA GRANUFLO Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 11/04/2005
Event Type  Death  
Event Description
The plaintiff's attorney alleged that the decedent experienced a cardiovascular event on or about (b)(6) 2005 and subsequently expired after the use of the product.
 
Manufacturer Narrative
This is one event (death) for the same pt involving two separate products.
 
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Brand Name
GRANUFLO
Manufacturer (Section D)
FRESENIUS MEDICAL CAR NORTH AMERICA
waltham MA
Manufacturer Contact
corie vazquez
920 winter street
waltham, MA 02451
7816999071
MDR Report Key4454199
MDR Text Key5429313
Report Number1225714-2015-00196
Device Sequence Number1
Product Code KPO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 01/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2015
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 Received01/07/2015
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Death;
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