BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23092710 · Received September 18, 2025

    Report

    Report Number
    3008737795-2025-00022
    Event Type
    Injury
    Date Received
    September 18, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW: PRODUCT MET SPECIFICATIONS PER DOCUMENTARY REVIEW. 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 (B)(6) 2020, THE PATIENT UNDERWENT PLACEMENT OF THE XCELA POWER INJECTABLE PORT PRODUCT: UPN H965451030; LOT #: 146020000, FOR HIS CHEMOTHERAPY. UPON INFORMATION AND BELIEF, THE AFOREMENTIONED DEVICE'S DESCRIPTION IS AS FOLLOWS: 8F X 750MM XCELA STANDARD TITANIUM POWER INJECTABLE PORT. ON (B)(6) 2020, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6) AT (B)(6). ON OR ABOUT (B)(6) 2020, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AT (B)(6), WITH A FEVER. ON OR AROUND (B)(6) 2020, THE PATIENT'S XCELA POR, WAS REMOVED BY DR. (B)(6), DO, (B)(6) HOSPITAL DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288180 XCELA PORT LJT PFM MEDICAL CPP SA N/A 146020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R