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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 NameFRESENIUS DIALYSIS EQUIPMENT
Type of DeviceFRESENIUS 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
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/21/2017 Patient Sequence Number: 1
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