BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOLINE

    MDR report key: 7079119 · Received December 1, 2017

    Report

    Report Number
    MW5073720
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 28, 2017
    Report Date
    November 30, 2017
    Manufacturer
    UNK
    Product Code
    KNG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM (B)(6) WEEKS PREGNANT - IN A FORUM I CAME TO KNOW ABOUT A PRODUCT CALLED BABYDOPPLER - I PURCHASED IT ONLINE ON THIS WEBSITE: (B)(6). COMPANY IS US BASED AND THEY SHIPPED IT TO MY ADDRESS. I USED THE DEVICE AS SHOWN ON THE VIDEO IN THE WEBSITE - AFTER 15 MINUTES USING THE PROBE TRYING TO SPOT THE BABY'S HEARTBEAT I HAD A FEELING OF BURNING ON MY SKIN - AFTER THAT I FOUND A BURN MARK ON MY SKIN AS BIG AS THE SIZE OF A COIN. I WAS REALLY AFRAID OF THE SYMPTOMS - I WENT TO MY OB AND HE TOLD ME THAT THIS DEVICE IS WIDELY AVAILABLE BUT WAS NEVER APPROVED BY FDA FOR USE BY PUBLIC. THE ULTRASOUND DEVICE COULD CREATE DEEP HEAT IN TISSUES AND HARM THE UNBORN BABY. I AM EXTREMELY DESPERATE, STRESSFUL, ANGRY AND HOPELESS. I CALLED THE COMPANY AND COULD NOT GET ANY RESPONSE FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853941 SONOLINE BABYDOPPLER KNG UNK B

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Congenital Anomaly| L| O