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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3842
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, after approximately 6 months, a hakim valve became occluded and was revised. The patient had polaris and the patient's condition improved but a half year later the ventricles did not become smaller therefore it was checked for contrast and there was almost no spinal fluid flowing. A removal surgery was performed and a third ventricular fenestration was performed. The surgeon suspected blood and debris contamination in the cerebrospinal fluid.
 
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Brand NameHAKIM PROG VALVE INLINE SIPHONGUARD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8138536
MDR Text Key129502870
Report Number1226348-2018-10842
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-3842
Device Lot Number171595
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2017
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: 12/06/2018 Patient Sequence Number: 1
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