BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT

    MDR report key: 18246344 · Received December 1, 2023

    Report

    Report Number
    3004160911-2023-02977
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 22, 2023
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017638
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS IN TRANSIT FOR RETURNED TO PEROUSE MEDICAL. WE ASKED MORE INFORMATION ABOUT THE INCIDENT (LOT, DATE IMPLANTATION, VENOUS ACCESS ROUTES, IMPLANTATION AND EXPLANTATION REPORTS, COPY OF X-RAY PICTURES FOR IMPLANTATION AND OBSERVATION OF EVENT, THE CONSEQUENCES FOR THE PATIENT, INSTALLER TRAINING). WE ARE WAITING FOR THE DEVICE IN ORDER TO PERFORM A TECHNICAL INVESTIGATION.

    Description of Event or Problem · 0

    PORT TUBING BECAME DISLODGED AND MIGRATED DOWN TO PATIENT'S HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452114 POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT PEROUSE MEDICAL 4018PI 03661234017638

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention