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Adverse Event Report

CODMAN & SHURTLEFF, INC./MEDOS S.A. HAKIM VENTRICULAR & PERITONEAL CATHETERS W/BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS   back to search results
Catalog Number 82-3072
Event Date 05/28/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The pt had a previous infection prior to valve implantation which seemed to clear up. However, after the bactiseal catheter was implanted, the infection reappeared and catheter was explanted. There is no claim that the infection has been attributed to the bactiseal catheter but the explanted catheter was returned for eval.

 
Manufacturer Narrative

The catheters have been returned for eval. Results will be forwarded to the fda upon completion of the eval.

 
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Brand NameHAKIM VENTRICULAR & PERITONEAL CATHETERS W/BACTISEAL
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS
Baseline Brand NameHAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL
Baseline Generic NameSHUNT, CENTRAL NERVOUS SYS & COMPS
Baseline Catalogue Number82-3072
Baseline Device FamilyHAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL
Baseline Device 510(K) NumberK003322
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed10/01/2001
Manufacturer (Section F)
CODMAN & SHURTLEFF, INC./MEDOS S.A.
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le locle
SWITZERLAND CH-2400
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC./MEDOS S.A.
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le locle
SWITZERLAND CH-2400
Manufacturer Contact
matthew king
325 paramount drive
raynham , MA 02767
(508) 828 -3106
Device Event Key456095
MDR Report Key467150
Event Key442710
Report Number1226348-2003-00131
Device Sequence Number1
Product CodeJXG
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 05/28/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number82-3072
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/28/2003
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/23/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,HAKIM VALVE 82-3113 WAS ALSO EXPLANTED BUT IS NOT,
2,THE SUBJECT OF A PRODUCT COMPLAINT.,

Database last updated on February 28, 2009

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