BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980

    MDR report key: 6198169 · Received December 20, 2016

    Report

    Report Number
    MW5066849
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 28, 2014
    Report Date
    December 20, 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

    PORT PLACED ON (B)(6) 2014, WAS TREATED WITH CHEMOTHERAPY UNTIL (B)(6) 2015. CHEMOTHERAPY WAS RESTARTED ON (B)(6) 2016, THE PORT WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. CATHETER WAS FRACTURED. THE SECOND PORT WAS IMPLANTED ON (B)(6) 2016 AND ON (B)(6) 2016 DYE STUDY REVEALED A FRACTURE IN THE CATHETER. THIS WAS EXPLANTED AND A NEW CATHETER WAS IMPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840387 PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980 PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980 LJT ANGIODYNAMICS/DIOMED INC H787CT80STPD 4807080
    840388 PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980 PORT POWER INJECTABLE SMART PORT SYSTEM LOG58980 LJT ANGIODYNAMICS/DIOMED INC H787CT80STPD 5074083

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization