BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAKIN PROGRAMMABLE VALVE, RT. ANGLE UNITIZED

    MDR report key: 495113 · Received November 11, 2003

    Report

    Report Number
    1226348-2003-00250
    Event Type
    Other
    Date Received
    November 11, 2003
    Report Date
    October 13, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUMAN HAIR WAS FOUND INSIDE THE PACKAGED DEVICE WHEN PREPARING THE PT FOR SURGERY. AS A RESULT, THERE WAS A DELAY OF APPROXIMATELY 45 MINUTES WHILE THE CUSTOMER OBTAINED A REPLACEMENT VALVE FOR IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIN PROGRAMMABLE VALVE, RT. ANGLE UNITIZED SHUNT, CENTRAL NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other