BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAPORT

    MDR report key: 20006 · Received January 19, 1995

    Report

    Report Number
    20006
    Event Type
    Injury
    Date Received
    January 19, 1995
    Date of Event
    October 16, 1994
    Report Date
    January 19, 1995
    Manufacturer
    STRATO MEDICAL CORP.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT INSERTED ON 9/18/94. PT DISCHARGED ON 10/6/94. 1/16/95 PT RETURNED TO HOSP COMPLAINING OF SHORTNESS OF BREATH. X-RAY REVEALED CATHETER HAD BROKEN OFF AND END WAS INTO RT ATRIUM. PT UNDERWENT ANGIOGRAPHY ON 1/17/95 TO RETRIEVE BROKEN CATHETER (SUCCESSFUL.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAPORT Implant INFUSAPORT LJT STRATO MEDICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R