BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDONIC M-SERIES

    MDR report key: 24799759 · Received April 7, 2026

    Report

    Report Number
    24799759
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 22, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BOULE MEDICAL AB
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDONIC DEVICE ASPIRATION FAILURE IN BOTH OPEN TUBE AND CAP PIERCING MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857585 MEDONIC M-SERIES COUNTER, DIFFERENTIAL CELL GKZ BOULE MEDICAL AB 48446

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other