BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASONIC 100

    MDR report key: 10307555 · Received July 21, 2020

    Report

    Report Number
    MW5095649
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 18, 2020
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    IYO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVELOPED HIVES AND RASH AFTER ECHOCARDIOGRAM USING AQUASONIC 100 GEL. MANUFACTURER (PARKER) WILL NOT DISCLOSE INGREDIENTS. I AM HIGHLY ALLERGIC TO MULTIPLE CHEMICALS, WITH PRESERVATIVES BEING THE WORST. I NEED TO IDENTIFY THE OFFENDING INGREDIENT TO MAKE SURE I AVOID THIS PRODUCT (IF IT DOES INCLUDE AN OFFENDING SUBSTANCE) IN THE FUTURE BUT WITHOUT THE INFORMATION REGARDING INGREDIENTS, I AM UNABLE TO DO SO. I SIMPLY NEED TO KNOW THE INGREDIENTS IN AQUASONIC 100 GEL AS I HAD A SEVERE REACTION THAT LAST 3 WEEKS. EACH TIME I AM EXPOSED TO ALLERGENS THE REACTION IS WORSE SO KNOWING INGREDIENTS IS KNOWING WHAT PRODUCTS TO AVOID. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766784 AQUASONIC 100 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO PARKER LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other