BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE INLINE UNIT (INTEGRAL CON)

    MDR report key: 1201479 · Received October 17, 2008

    Report

    Report Number
    1226348-2008-00273
    Event Type
    Injury
    Date Received
    October 17, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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

    REPRESENTATIVE REPORTED THAT THE CAM APPEARS TO HAVE BECOME LOOSE FROM BASEPLATE, REQUIRING REVISION OF VALVE. PATIENT IS FINE FOLLOWING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE INLINE UNIT (INTEGRAL CON) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention