BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTRICULAR CATHETER STRAIGHT

    MDR report key: 1328173 · Received February 26, 2009

    Report

    Report Number
    1226348-2009-00028
    Event Type
    Other
    Date Received
    February 26, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    AFFILIATE REPORTED THAT AT THE AGE OF (B) (6), THE PATIENT WAS IMPLANTED WITH A MEDTRONIC VALVE AND A CODMAN CATHETER. AT (B) (6), THE PATIENT HAD A BLOCKAGE AND WAS REPLACED WITH THE SAME PRODUCT. AT (B) (6), THE PATIENT WAS PRESENTED WITH ANOTHER BLOCKAGE AND AN ALLERGIC REACTION TO THE MATERIAL. THE SURGEON MADE IT CLEAR THAT HE IS NOT COMPLAINING ABOUT THE DEVICE AS HE IS AWARE THIS DEVICE CAN BECOME BLOCKED. HE IS HOWEVER, INQUIRING ABOUT THE MATERIAL THE DEVICE IS MADE OF. IT HAS ALSO BEEN NOTED THAT THE PATIENT HAS ALSO HAD A REACTION TO THE HOSPITAL BRACELET. AS A CONSERVATIVE MEASURE CODMAN IS REPORTING THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR CATHETER STRAIGHT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC/MEDOS S.A. NA CJBB7B (1EA.) & CHKB7V

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO