BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE WITH INLINE RESERVOIR

    MDR report key: 481831 · Received September 8, 2003

    Report

    Report Number
    1226348-2003-00196
    Event Type
    Injury
    Date Received
    September 8, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 8, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANTED VALVE'S PRESSURE COULD NOT BE CHANGED AND THE DEVICE WAS EXPLANTED. THE VALVE WAS IMPLANTED IN 05/2003 (EXACT DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM VALVE WITH INLINE RESERVOIR SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention