BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 17722 · Received July 29, 1994

    Report

    Report Number
    17722
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    April 13, 1994
    Report Date
    May 19, 1994
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A LEFT MODIFIED RADICAL MASTECTOMY IN JANUARY 1, 1994 AND AN IMMEDIATE BREAST RECONSTRUCTION. A EXPANDER WITH A TEXTURED SURFACE WAS IMPLANTED AND FILLED WITH 120CC NORMAL SALINE.ON JANUARY 20, 1994 A DIAGNOSIS OF CELLULITIS ON THE LEFT BREAST AND ISOLATION OF STAPHYLOCOCCUS AUREUS REQUIRED EXPLANTATION OF THE PROSTHESIS. THE PATIENT WAS DISCHARGED ON ORAL ANTIBIOTICS.ON MARCH 4, 1994, A CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT CHEST FOR CHEMOTHERAPY. ON APRIL 13, 1994, THE CATHETER SPLIT AND REQUIRED SURGICAL REMOVAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD Implant DOME SUBCUTANEOUS PORT WITH GROSHONG CATHETER LJT BARD ACCESS SYSTEMS UNKNOWN 36AE6870

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention