BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PORT

    MDR report key: 670601 · Received February 1, 2006

    Report

    Report Number
    2242445-2006-00009
    Event Type
    Injury
    Date Received
    February 1, 2006
    Date of Event
    October 15, 2005
    Report Date
    January 31, 2006
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SEE 2242445-2006-00008. FOR FIRST EVENT INVOLVING SAME PATIENT.IT WAS REPORTED THAT PATIENT COMPLAINED OF SWELLING, PAIN AND REDNESS AT PORT SITEIN OCTOBER 2005. PATIENT RETURNED TO HOSPITAL FOR EXAMINATION. USER FOUND CATHETER DETACHED FROM PORT. PORT & CATHETER WERE SURGICALLY REMOVED FROM PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PORT THEREX IMPLANTABLE PORT LJT ARROW INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention