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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIDNEY DIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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KIDNEY DIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Myocardial Infarction (1969)
Event Date 09/11/2021
Event Type  Death  
Event Description
(b)(6) had kidney dialysis at (b)(6) hospital and had a heart attack he was told to take dialysis to get a heart surgery but he had a really bad kidney disease. He was visiting the (b)(6) hospital because of heart attack. They never attend his medical history from the (b)(6) put them on kidney dialysis lead to death. Fda safety report id# (b)(4).
 
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Brand NameKIDNEY DIALYSIS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
MDR Report Key12727827
MDR Text Key279559638
Report NumberMW5105027
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 10/29/2021 Patient Sequence Number: 1
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