BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERO CATHETER

    MDR report key: 2121093 · Received June 8, 2011

    Report

    Report Number
    MW5020948
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    March 24, 2011
    Report Date
    June 2, 2011
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH END STAGE RENAL DISEASE ADMITTED TO HOSPITAL WITH SEPSIS. ON (B)(6) 2011, PT IDENTIFIED AS HAVING CATHETER LINE SEPSIS AND UNDERWENT SURGICAL REMOVAL OF HERO CATHETER AND INSERTION OF TEMPORARY DIALYSIS CATHETER. AT TIME OF REMOVAL, THE HERO CATHETER WAS FOUND TO HAVE SOME FRACTURES IN IT. AND AREA OF CLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERO CATHETER MSD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other