BEUDAMED
    FDA Adverse Event Death Summary report: N

    Z-5 ATRIOSEPTOSTOMY CATHETER

    MDR report key: 1343177 · Received March 11, 2009

    Report

    Report Number
    9618000-2009-00001
    Event Type
    Death
    Date Received
    March 11, 2009
    Report Date
    March 10, 2009
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    DXF
    PMA / PMN Number
    K960070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS REPORTED TO MFR VIA EMAIL IN 2009. WE HAVE BEEN UNABLE TO CONFIRM IF THIS PRODUCT IS OURS OR EXACTLY WHAT HAPPENED. MORE INFORMATION IS SUPPOSED TO BE FORTHCOMING FROM THE DISTRIBUTOR IN OTHER COUNTRY. ONCE WE RECEIVE THIS INFORMATION, WE WILL SEND IT IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    DEATH OF PATIENT. CO HAS NOT YET BEEN ABLE TO CONFIRM THAT THE PRODUCT IS OUR ATRIOSEPTOSTOMY CATHETER. WE HAVE TRIED CONTACTING OUR DISTRIBUTOR, AND HE IS SUPPOSED TO TRY AND GET US MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-5 ATRIOSEPTOSTOMY CATHETER SEPTOSTOMY CATHETER DXF NUMED CANADA, INC. 210 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death