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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM NERVOUS SYSTEM AND SHUNT CENTRAL COMPONENTS

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INTEGRA NEUROSCIENCES PR LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM NERVOUS SYSTEM AND SHUNT CENTRAL COMPONENTS Back to Search Results
Catalog Number INS-9030
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2018
Event Type  Injury  
Event Description
The csf monitoring system had a port break off the stopcock.
 
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Brand NameLIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Type of DeviceNERVOUS SYSTEM AND SHUNT CENTRAL COMPONENTS
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
plainsboro NJ 08536
MDR Report Key8069506
MDR Text Key127246931
Report NumberMW5081208
Device Sequence Number0
Product Code JXG
Combination Product (y/n)N
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 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberINS-9030
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2018 Patient Sequence Number: 1
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