BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PORT

    MDR report key: 5083591 · Received September 17, 2015

    Report

    Report Number
    5083591
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CHEST WALL MEDIPORT MALFUNCTIONED. THE MEDIPORT HAD TO BE REMOVED AND REPLACED. THIS SUBJECTED THE PATIENT TO AN ADDITIONAL SURGERY. MANUFACTURER RESPONSE FOR SMART PORT MEDIPORT, SMART PORT POWER INJECTABLE PORT (PER SITE REPORTER): THEY PROVIDED A RETURN SHIPPING LABEL AND ASSURED ME THAT AN INVESTIGATION WOULD BE CONDUCTED INTO THE DEVICE'S MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616446 SMART PORT PORT AND CATHETER LJT ANGIODYNAMICS, INC 4877586

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other CHEMOTHERAPY