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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3832
Device Problem Obstruction of Flow (2423)
Patient Problem Failure of Implant (1924)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
Udi -- (b)(4). Attempts are being made to obtain additional information. Upon receipt of new relevant information, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, after a month, a hakim programmable valve with siphonguard was suspected of being obstructed and was revised. Blood was confirmed to be in the removed valve. The product will be returned.
 
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Brand NamePROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8190468
MDR Text Key131187568
Report Number1226348-2018-10910
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-3832
Device Lot Number184541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
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: 12/21/2018 Patient Sequence Number: 1
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