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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN HAKIM VAVLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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UNKNOWN HAKIM VAVLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK HAKIM
Device Problem Device Operational Issue (2914)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number. It is not clear at this point if the device and/or lot information is available. Without the device and/or lot information it is not possible for codman to conduct a proper investigation. If the device is returned the complaint will be investigated and a follow up report will be filed. If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is closed. Device not available.
 
Event Description
Patient reported that a fixed pressure valve that was implanted in 1983 is not working properly after a car accident. Pateint reports vision issues and light related seizures. Valve is reported to feel out of place with discomfort. Patient is seeking information about the shunt to see if it can be tapped. No specific device failure has been reported. The device remains implanted.
 
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Brand NameUNKNOWN HAKIM VAVLE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7245908
MDR Text Key99181181
Report Number1226348-2018-10109
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 other
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HAKIM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2018
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 Treatment Data
Date Received: 02/06/2018 Patient Sequence Number: 1
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