BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIPHONGUARD, CSF FLD CONTRL DEVICE

    MDR report key: 1201480 · Received October 17, 2008

    Report

    Report Number
    1226348-2008-00275
    Event Type
    Injury
    Date Received
    October 17, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DR THOUGHT SHE SAW THAT THE INSIDE PART OF THE VALVE HAD TURNED OUT FROM IT'S OUTER SHELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention