BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED PORT

    MDR report key: 67270 · Received February 7, 1997

    Report

    Report Number
    MW1010680
    Event Type
    Injury
    Date Received
    February 7, 1997
    Date of Event
    January 28, 1997
    Report Date
    January 30, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    12/8/95 INITIAL INSERTION. 2/26/96 PORT CLOGGED AND REMOVED WITH NEW ONE INSERTED. 1/28/97 CATHETER NON-FUNCTIONING AND INFECTED; CATHETER REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTED PORT Implant IMPLANTED PORT LJT BARD ACCESS SYSTEMS PRODUCT CODE: 0603590 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention