BEUDAMED
    FDA Adverse Event Summary report: N

    AQUASONIC 100

    MDR report key: 2137108 · Received June 20, 2011

    Report

    Report Number
    2137108
    Date Received
    June 20, 2011
    Date of Event
    June 15, 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 INFANT WITH A HISTORY OF STAGE II HEPATOBLASTOMA REQUIRED RIGHT HEPATIC LOBECTOMY AND CHEMOTHERAPY. SHE UNDERWENT AN ULTRASOUND (US). THE PARENTS CALLED THE CLINIC WHERE THE US WAS PERFORMED AND STATED THAT THEY HAD TO TAKE THE CHILD TO THE EMERGENCY DEPARTMENT AS THE CHILD DEVELOPED HIVES IN THE AREA WHERE THE US WAS PERFORMED. SHE DID NOT RETURN TO OUR HOSPITAL'S EMERGENCY DEPARTMENT, SO WE HAVE NO INFORMATION ABOUT THE EXAM OR TREATMENT.

    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 PROBE LRJ CIVCO MEDICAL SOLUTIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO IMMUNOTHERAPY