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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO-GAV MEIETHKE CATHETER VENTRICULAR PERITONEAL CATHETER

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PRO-GAV MEIETHKE CATHETER VENTRICULAR PERITONEAL CATHETER Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Code Available (3191)
Event Date 08/17/2016
Event Type  Injury  
Event Description
Removed due to suspected malfunction per surgeon. Sent to risk management and back to manufacture for device evaluation for further testing of device per surgeon request.
 
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Brand NamePRO-GAV MEIETHKE CATHETER
Type of DeviceVENTRICULAR PERITONEAL CATHETER
MDR Report Key5895877
MDR Text Key52863686
Report NumberMW5064251
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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: 08/19/2016 Patient Sequence Number: 1
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