BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS

    MDR report key: 20891539 · Received December 10, 2024

    Report

    Report Number
    20891539
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 3, 2024
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FPD
    UDI-DI
    10817522011967
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SEVERAL INCIDENTS OF NEONATAL FEEDING TUBE CAP BREAKAGE REQUIRING REMOVAL AND REPLACEMENT OF FEEDING TUBES. MANUFACTURER RESPONSE FOR TUBE, FEEDING, AMERITUS (PER SITE REPORTER) UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677576 AMERITUS TUBE, FEEDING FPD KENTEC MEDICAL, INC. AEG-60P-80 KS2404004 10817522011967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female