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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS ADJUSTABLE BRAIN SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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INTEGRA LIFESCIENCES CORPORATION CODMAN CERTAS ADJUSTABLE BRAIN SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Swelling (2091)
Event Date 08/16/2020
Event Type  Death  
Event Description
My child's brain swelled for two years and i insisted it was his brain shunt. The doctors kept shutting me down. Long behold it killed him. Fda safety report id# (b)(4).
 
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Brand NameCODMAN CERTAS ADJUSTABLE BRAIN SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
MDR Report Key10579502
MDR Text Key208584170
Report NumberMW5096826
Device Sequence Number1
Product Code JXG
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 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
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: 09/23/2020 Patient Sequence Number: 1
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