BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOUND SCANNER

    MDR report key: 7922583 · Received September 28, 2018

    Report

    Report Number
    MW5080227
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 27, 2018
    Manufacturer
    UNK
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ABOUT AN HOUR AFTER A PELVIC ULTRASOUND/TRANSVAGINAL ULTRASOUND, I STARTED TO HAVE LABOR-LIKE PAIN. I STARTED FEELING BLOATED. I GOT SHARP PAIN WHEN EATING SOLID FOOD. ON THE SECOND DAY, I STARTED HEARING GANGLING AND BUDDLING IN MY ABDOMEN. I HAVE PREVIOUSLY HAD HEAT SENSATION FROM ULTRASOUND AND INFORMED THE TECH PRIOR TO THE PROCEDURE. I SUSPECT THAT I SUFFERED CAVITATION (GAS FORMATION) FROM THE ULTRASOUND. I AM STILL IN SEVERE PAIN. TRANSVAGINAL ULTRASOUND WAS PERFORMED AT RUSH MEDICAL CTR, RADIOLOGY, CHICAGO IL. I CALLED THE CLINIC AND ASKED THEM TO CHECK THEIR EQUIPMENT, AND AMEND MY RECORD WITH THE AFTER-EFFECTS. THE RECORDS WAS NOT AMENDED. MY CONCERNS WAS IGNORED. PROPERTY OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762003 ULTRASOUND SCANNER ULTRASOUND SCANNER IYN UNK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| S