BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTROL DEVICE

    MDR report key: 732121 · Received July 6, 2006

    Report

    Report Number
    1226348-2006-00183
    Event Type
    Injury
    Date Received
    July 6, 2006
    Date of Event
    June 5, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED THE VALVE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTS THAT IT WAS FOUND BY X-RAY THAT THE CONNECTOR OF THE SIPHONGUARD WAS BROKEN AND NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIPHONGUARD, CSF FLD CONTROL DEVICE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC/MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention