BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL UNIVERSAL SHUNT, M

    MDR report key: 2212683 · Received August 11, 2011

    Report

    Report Number
    1226348-2011-00307
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 16, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K904120
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT IS BEING FILED TO NOTIFY YOU THAT THE PRODUCT ASSOCIATED WITH THIS COMPLAINT IS NOT DISTRIBUTED IN THE UNITED STATES. AS A RESULT NO ADDITIONAL REPORTS WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES AND OR CATHETERS HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE DEVICE, WHICH HAVE RESULTED IN BLOCKAGES. REVIEW OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FIELD IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    SHUNT BLOCKAGE AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTISEAL UNIVERSAL SHUNT, M SHUNT, CNS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA 446505

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention