BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUASONIC CLEAR

    MDR report key: 21421903 · Received February 20, 2025

    Report

    Report Number
    MW5166532
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 15, 2025
    Report Date
    February 19, 2025
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCED SEVERE BURNING SENSATION FROM TWO RECENT TRANS-VAGINAL ULTRASOUNDS. THE ULTRASOUNDS WERE TAKEN AT (B)(6). ON (B)(6) 2024, THE FIRST TRANS-VAGINAL ULTRASOUND WAS PERFORMED. ON (B)(6) 2025, THE SECOND ULTRASOUND WAS PERFORMED. THE BURNING SENSATION WAS MUCH MORE SEVERE IN FEBRUARY. THE GEL WAS WARMED AT BOTH INCIDENTS BEFORE APPLICATION ONTO THE PATIENT. IMMEDIATELY AFTER THE ULTRASOUND, THE PATIENT MADE THE TECHNICIAN AWARE OF THE SENSATION AND THEY ASSURED HER IT WAS NORMAL. HOURS AFTER THE SENSATION DIDN'T GO AWAY BUT INTENSIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044769 AQUASONIC CLEAR MEDIA, COUPLING, ULTRASOUND MUI PARKER LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other