BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITH'S MEDICAL

    MDR report key: 1627629 · Received March 9, 2010

    Report

    Report Number
    1627629
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 5, 2010
    Manufacturer
    SMITH'S MEDICAL
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMITH MEDICAL POWER PORT WAS IMPLANTED ON (B) (6) 2009. REMOVED (B) (6) 2010 DUE TO TISSUE REJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH'S MEDICAL POWER PORT LJT SMITH'S MEDICAL 21-8468-24 M76293

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention