BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 23181031 · Received September 30, 2025

    Report

    Report Number
    MW5176783
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Report Date
    September 26, 2025
    Manufacturer
    KORU MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LAMBERT-EATON SYNDROME IN DISEASE CLASSIFIED ELSEWHERE. PATIENT REPORTS TUBES ARE CHEAP AND LEAKING. LOT IS NOT AVAILABLE. UNKNOWN IF PT MISSED ANY DOSES OR ADVERSE EVENT OCCURRED. PATIENT PROVIDED NO ADDITIONAL INFORMATION AT THE TIME OF THE REPORT. ALL KNOWN INFORMATION IS INCLUDED ON THIS FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795244 TUBING FREEDOM 60 SYR INF PUMP, INFUSION FRN KORU MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female