BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 19277036 · Received May 9, 2024

    Report

    Report Number
    19277036
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE BONE SCALPING TUBING WAS CONNECTED IT WAS LEAKING, WHERE THE TUBING AND THE CONNECTOR MET, SAVED TUBING AND PACKAGING AND GAVE TO QUALITY NURSE. LOT NUMBER 233200 MANUFACTURER RESPONSE FOR INSTRUMENT, ULTRASONIC SURGICAL, NEXUS (PER SITE REPORTER). NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548433 NEXUS INSTRUMENT, ULTRASONIC SURGICAL LFL MISONIX, INC. 110-31-1120 233200

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male