BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT TITANIUM ATTACHABLE SYS

    MDR report key: 35530 · Received July 1, 1996

    Report

    Report Number
    35530
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    January 1, 1996
    Report Date
    June 30, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PART OF A PORT-A-CATH WAS FOUND TO BE EMBOLIZED TO THE PULMONARY VESSELS IN 1/96. PT WAS TRANSFERRED TO HOSP AT WHICH POINT THE EMBOLIZED SEGMENT WAS REMOVED VIA INTERVENTIONAL RADIOLOGY. PT RETURNED, WITH RESPECT TO REMOVAL OF THE REMAINDER OF THE PORT-A-CATH. A RIGHT SUBCLAVIAN PORT-A-CATH WAS REMOVED WITH NO COMPLICATIONS AND NO DIFFICULTIES WERE NOTED IN A SUBSEQUENT FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT TITANIUM ATTACHABLE SYS PORT-A-CATH LJT STRATO/INFUSAID, INC. LPS 5513 UN; PCR #014010

    Patients

    Seq Age Sex Outcome Treatment
    1 *