BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEMO-PORT

    MDR report key: 527597 · Received June 1, 2004

    Report

    Report Number
    2925153-2004-00005
    Event Type
    Injury
    Date Received
    June 1, 2004
    Date of Event
    May 5, 2004
    Report Date
    May 26, 2004
    Manufacturer
    HDC CORP.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PORT WAS PLACED 2 1/2 YEARS AGO. PORT BROKE IN THE PT. PORT SEPARATED FROM CATHETER. FRACTURED SUBCUTANEOUS VASCULAR ACCESS PORT, REQUIRING ENDOVASCULAR RETRIEVAL OF FRACTURED CATHETER FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO-PORT CHEMO-PORT LJT HDC CORP. 735-06-15 1004

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other