BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DY

    MDR report key: 1220786 · Received October 31, 2008

    Report

    Report Number
    1317749-2008-00179
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 24, 2008
    Manufacturer
    COVIDIEN
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2008, THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE CATHETER HAD TO BE EXCHANGED DUE TO POOR TISSUE GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DY DIALYSIS CATHETER MPB COVIDIEN UNK DY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK