BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 23057161 · Received September 15, 2025

    Report

    Report Number
    3008737795-2025-00020
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 11, 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

    WITHOUT PRODUCT REFERENCE/BATCH # AND RETURN PRODUCT, THE MANUFACTURER COULD NOT CONDUCT NEITHER PRODUCT INVESTIGATION NOR DOCUMENTARY REVIEW. THEREFORE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT "PURULENT DISCHARGE/INFECTION". THE RELATED RISK IS IDENTIFIED IN OUR RISK MANAGEMENT FILE. 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 UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT, MODEL NUMBER H965451270. THE DEVICE WAS IMPLANTED AT (B)(6) HOSPITAL, (B)(6). ON OR ABOUT (B)(6) 2023, PATIENT PRESENTED AT (B)(6) HOSPITAL, WITH DISCHARGE FROM THE PORT SITE. ON OR ABOUT (B)(6) 2023, PATIENTS PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398561 XCELA PORT LJT PFM MEDICAL CPP SA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention