BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23097536 · Received September 19, 2025

    Report

    Report Number
    3008797795-2025-00027
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    November 6, 2019
    Report Date
    September 19, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    UNKNOWN
    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 LIST OF BATCHES 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) 2019, PATIENT PRESENTED HIMSELF TO (B)(6), WITH COMPLAINTS THAT THE SKIN ABOVE THE XCELA PORT HAD A HOLE THAT WAS BLEEDING AND HAD INCREASED IN SIZE. PATIENT'S MEDICAL TEAM DETERMINED THAT PATIENT WAS SUFFERING FROM WOUND DEHISCENCE. PATIENT'S MEDICAL TEAM ADVISED HIM THAT THE PORT NEEDED TO BE EXPLANTED. ON OR ABOUT (B)(6) 2019 THE XCELA PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982532 XCELA PORT LJT PFM MEDICAL CPP SA N/A UNKNOWN

    Patients

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