BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD

    MDR report key: 2010748 · Received March 2, 2011

    Report

    Report Number
    1226348-2011-00090
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 9, 2011
    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 Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE VALVE RUPTURED, CAUSING A LEAK WHICH RESULTED IN A REVISION. THE PT WAS SAID TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CLKCTT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention