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U.S. Department of Health and Human Services

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

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UNKNOWN HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 823XXX
Device Problem Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Udi: unknown product code, gtin unavailable. Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the rep, a chpv malfunctioned and was revised.
 
Manufacturer Narrative
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
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Brand NameUNKNOWN HAKIM VALVE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7296093
MDR Text Key100917376
Report Number1226348-2018-10184
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2015
Device Catalogue Number823XXX
Device Lot NumberCLBB5L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2010
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: 02/26/2018 Patient Sequence Number: 1
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