BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCLEA

    MDR report key: 23059593 · Received September 15, 2025

    Report

    Report Number
    3008737795-2025-00021
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    November 28, 2023
    Report Date
    September 15, 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: 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 OR ABOUT (B)(6) 2023, PATIENT PRESENTED TO SPRINGFIELD CLINIC MAIN CAMPUS WITH COMPLAINTS OF SWELLING. IMAGING PERFORMED DURING THE VISIT REVEALED THAT THE PATIENT HAD DEVELOPED ACUTE DEEP VEIN THROMBOSIS. HIS INJURIES WERE TREATED WITH MEDICATION. ON OR ABOUT (B)(6) 2024, PATIENT AGAIN PRESENTED TO SPRINGFIELD CLINIC MAIN CAMPUS. IMAGING PERFORMED DURING THE VISIT REVEALED A NEW NON-OCCLUSIVE THROMBUS AND PATIENT'S INJURIES WERE TREATED WITH MEDICATION. ON OR ABOUT (B)(6) 2024, PATIENT PRESENTED TO (B)(6) HOSPITAL, FOR PORT REMOVAL. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271269 XCLEA PORT LJT PFM MEDICAL CPP SA N/A 152128000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention