BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 707151 · Received May 2, 2006

    Report

    Report Number
    1226348-2006-00092
    Event Type
    Injury
    Date Received
    May 2, 2006
    Date of Event
    March 1, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFFILIATE REPORTS THAT FLUID DID NTO FLOW THROUGHTHE DEVICE BECAUSE THE BREAKAGE OF THE CATHETER WHICH NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention