BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23831169 · Received December 17, 2025

    Report

    Report Number
    3008797795-2025-00043
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    January 1, 2017
    Report Date
    December 17, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW ON THE BATCH PROVIDED: NO DEVIATION WAS FOUND. WITHOUT RETURNED PRODUCT FOR TECHNICAL INVESTIGATION, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. THE RELATED RISKS ARE IDENTIFIED IN OUR RISK MANAGEMENT FILE AND PROCEDURE CLEARLY DESCRIBED IN THE IFU. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2013, PATIENT UNDERWENT PLACEMENT OF THE OF THE ANGIODYNAMICS XCELA PORT, LOT NUMBER 130850. THE DEVICE WAS IMPLANTED AT (B)(6). IN 2017, HER PORT WAS SUBSEQUENTLY REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182506 XCELA PORT LJT PFM MEDICAL CPP SA 130850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L