BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASONIC 100

    MDR report key: 23405219 · Received October 28, 2025

    Report

    Report Number
    MW5178102
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 20, 2025
    Report Date
    October 22, 2025
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    IYO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD AN ECHOCARDIOGRAM AT MY CARDIOLOGIST'S OFFICE 24HR LATER RECEIVED A SEVERE BURN LIKE SKIN REACTION UNDER THE LEFT ARM AND A SMALLER REACTION UNDER THE RIGHT. THIS I FEEL WAS FROM THE GEL USED IN THIS PROCEDURE. I'VE HAD MANY ECHOCARDIOGRAMS AND THIS HAS NEVER HAPPENED BEFORE SOMEBODY SHOULD'VE WARNED ME THAT THIS COULD HAPPEN! I FEEL THAT THE PRODUCT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213850 AQUASONIC 100 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PARKER LABORATORIES, INC. 100 1124744 2029-11-21

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention BYSTOLIC ARMOUR THYROID | ELIQUIS. | ENSTRO.| IOSORBIDE MONO NITRATE. | LEFLUNOMIDE. | MELATONIN.