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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BALLOON PUMP

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BALLOON PUMP Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Improper Device Output (2953)
Patient Problems Vascular System (Circulation), Impaired (2572); No Code Available (3191)
Event Date 06/20/2013
Event Type  Other  
Event Description
Balloon pump incorrectly installed by untrained pa causing blood flow to lower body to be cut off. This led to the amputation of right foot and decreased blood flow to left leg and foot.
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Type of DeviceBALLOON PUMP
MDR Report Key6124736
MDR Text Key60876885
Report NumberMW5066283
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2016 Patient Sequence Number: 1