BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT POWER INJECTABLE SMART PORT SYSTEM

    MDR report key: 6186304 · Received December 15, 2016

    Report

    Report Number
    MW5066785
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ANGIODYNAMICS/DIOMED INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 DURING EXPLANT OF POWER PORT, IT WAS FOUND TO BE FRAGMENTED, INTERVENTIONAL RADIOLOGY CONSULTED, PT TAKEN TO CATH LAB FOR REMOVAL OF REMAINING CATHETER FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826920 PORT POWER INJECTABLE SMART PORT SYSTEM SMART PORT CT LJT ANGIODYNAMICS/DIOMED INC. LOG589804 5027268

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization