BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23092757 · Received September 19, 2025

    Report

    Report Number
    3008737795-2025-00023
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    July 5, 2023
    Report Date
    August 22, 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 MEETS ITS 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 RISKS ANALYSIS AND OCCURRENCE'S RATE BELOW DEFINED ACCEPTABLE FREQUENCY. THEREFORE, COMPLAINT IS CLASSIFIED AS NO DEFINITIVE CONCLUSION, UNVERIFIABLE (NO RETURN PRODUCT).

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT UNDERWENT PLACEMENT OF THE XCELA POWER INJECTABLE PORT PRODUCT: UPN H965451090; LOT #: 149612000, FOR HER CHEMOTHERAPY. ON (B)(6) 2022, THE DEVICE AT ISSUE WAS IMPLANTED BY DR. (B)(6). ON OR ABOUT (B)(6) 2023, THE PATIENT PRESENTED TO (B)(6) HER XCELA PORT WAS REMOVED BY DR. (B)(6) DUE TO A LEAK AND IT WAS FOUND THAT THE TUBING HAD CRACKED. AFTER REMOVAL OF THE XCELA PORT, PATIENT DID NOT HAVE AN OPPORTUNITY TO CONSULT WITH HER DOCTOR ABOUT THE CAUSE OF HER FRACTURE. IT WAS IN (B)(6) 2023, WHEN PATIENT FIRST BECAME AWARE THAT INFECTION MAY BE RELATED TO XCELA PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269337 XCELA PORT LJT PFM MEDICAL CPP SA N/A 149612000

    Patients

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