BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA PLASTIC/TITANIUM PORT

    MDR report key: 3890192 · Received June 2, 2014

    Report

    Report Number
    3890192
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    ---
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    XCELA POWER INJECTABLE PORT WAS EXPLANTED ON (B)(6) 2014. PRE AND POST IMAGES WERE OBTAINED. PT RETURNED WITH CONCERN THAT HE HAD RETAINED OBJECT UNDER INCISION LINE. PLASTIC HUB WHICH CONNECTS THE PORT TO THE CATHETER WAS NOTED TO BE RETAINED IN THE PT AND WAS REMOVED (B)(6) 2014. CONNECTOR CANNOT BE SEEN ON X-RAY AS IT IS RADIO-TRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321964 XCELA PLASTIC/TITANIUM PORT POWER PORT --- ANGIODYNAMICS NI 130333000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention