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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS VALVES; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS VALVES; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
A review of events between september 2019 and march 2020 involving the codman valves and codman catheters showing: 1.Increase rate of infections and/or return to or within 30 days after ventriculoperitoneal shunt placement/revision related to either a catheter or a valve issues of unknown reasons: began using a variety of codman certas valves (b)(6) 2018.Began using codman bactiseal catheter (b)(6) 2019.In discussions with the neurosurgery team, they expressed concerns about the design and function of the product.Currently, we are in communication with our codman representative and the neurosurgeons have decided to limit use of codman bactiseal catheters and certas valves, as much as possible while investigation is being completed.Fda safety report id #: (b)(4).
 
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Brand Name
CODMAN CERTAS VALVES
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
princeton NJ 08540
MDR Report Key10104891
MDR Text Key194038657
Report NumberMW5094756
Device Sequence Number1
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 Risk Manager
Type of Report Initial
Report Date 05/27/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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