BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23808831 · Received December 15, 2025

    Report

    Report Number
    3008797795-2025-00038
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 27, 2019
    Report Date
    December 12, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2019, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PORT CATHETER PRODUCT, LOT NUMBER 144098000. THE DEVICE WAS IMPLANTED BY DR. (B)(6). ON OR ABOUT (B)(6) 2019, PATIENT PRESENTED TO (B)(6) MEDICAL CENTER WITH FEVER, WITH INCREASED PAIN. PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH AN INFECTION. ON OR ABOUT (B)(6) 2019, PATIENT'S PORT WAS REMOVED BY DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735885 XCELA PORT LJT PFM MEDICAL CPP SA 144098000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R