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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERTAS PLUS VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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CERTAS PLUS VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Device Problem Programming Issue (3014)
Patient Problem No Information (3190)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Udi: unknown product code.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Device not available.
 
Event Description
As reported by the rep, a certas plus valve changed settings from 3 to 6 after patient received an mri.There were no reports of delay or patient harm.
 
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Brand Name
CERTAS PLUS VALVE
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7096800
MDR Text Key95055369
Report Number1226348-2017-10933
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
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? No
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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