BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIALMIX®RFID DEFINITY

    MDR report key: 22529697 · Received July 17, 2025

    Report

    Report Number
    22529697
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 15, 2025
    Manufacturer
    LANTHEUS MEDICAL IMAGING, INC.
    Product Code
    EFD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TWO DEFINITY REACTIONS: 1. [DATE REDACTED] ---LOT # 1366 ---IMMEDIATELY AFTER ECHO [ECHOCARDIOGRAM] WAS COMPLETED, PATIENT HAD EXCRUCIATING BACK PAIN AND CHEST PAIN. PAIN RESOLVED AFTER A FEW MINUTES. 2. [DATE REDACTED] ----LOT# 6372 ---APPROX 10-15 MINUTES AFTER ECHO COMPLETED, PATIENT HAD 10/10 PAIN IN HIS UPPER HIP AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914849 VIALMIX®RFID DEFINITY AMALGAMATOR, DENTAL, AC-POWERED EFD LANTHEUS MEDICAL IMAGING, INC. VMIX2 1366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other