BEUDAMED
    FDA Adverse Event Summary report: N

    AQUASONIC 100

    MDR report key: 2137129 · Received June 20, 2011

    Report

    Report Number
    2137129
    Date Received
    June 20, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 20, 2011
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    GYB
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FEMALE CHILD HAD A LEFT RETROPERITONEAL GANGLIONEUROMA WHICH WAS PARTIALLY REMOVED. A URETERAL STENT WAS PLACED AT THE TIME OF SURGERY. THE TUMOR WAS BENIGN. SHE WAS SEEN IN CLINIC FOR AN ULTRASOUND (US) TO EVALUATE THE MASS. AFTER THE US, SHE COMPLAINED OF ITCHINESS AND REDNESS IN THE AREA WHERE THE US WAS PERFORMED. LATER IN THE DAY, SHE DEVELOPED HIVES IN THE SAME AREA. WE HAVE NO INFORMATION ABOUT FOLLOW UP CARE FOR THE HIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASONIC 100 ULTRASOUND TRANSMISSION GEL GYB PARKER LABORATORIES, INC. * C691
    2 T-SPRAY II DISINFECTANT USED TO CLEAN US PROBE LRJ CIVCO MEDICAL SOLUTIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR