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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE FRESENIUS DIALYSIS EQUIPMENT

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FRESENIUS MEDICAL CARE FRESENIUS DIALYSIS EQUIPMENT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Hepatitis (1897)
Event Date 12/08/2017
Event Type  Injury  
Event Description
I have been attending dialysis at (b)(6) since 2014.
 
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Brand Name
FRESENIUS DIALYSIS EQUIPMENT
Type of Device
FRESENIUS DIALYSIS EQUIPMENT
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
MDR Report Key7142186
MDR Text Key95737873
Report NumberMW5074189
Device Sequence Number0
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age34 YR
Patient Weight54
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