BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOLINE

    MDR report key: 7063440 · Received November 28, 2017

    Report

    Report Number
    MW5073582
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 20, 2017
    Report Date
    November 24, 2017
    Manufacturer
    DAGAMMA INC.
    Product Code
    KNG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY SISTER ASKED ME TO PURCHASE THIS PRODUCT IN (B)(6) WEBSITE - THE PRODUCT WAS PURCHASED EASILY AND SHIPPED TO OUR PLACE. THE PRODUCT INDICATED ON THE BOX AS SAFE AND RECOMMENDED BY DOCTORS. MY SISTER IS PREGNANT AT (B)(6). THE DEVICE CLAIMS TO BE HELPING RELIEVING ANXIETY IN PREGNANT LADIES HELPING THEM TO LISTEN TO THE UNBORN BABY HEARTBEAT. MY SISTER TRIED USING THE DEVICE FOR 15 MINUTES TO SPOT THE HEARTBEAT - SHE GOT A FEELING OF RASH AND OVERHEATING ON HER SKIN AND HER SKIN BURNT - SHE IMMEDIATELY HAD TO GO TO THE HOSPITAL - HER OBSTETRICIAN ADVISED STRONGLY AGAINST THE USE OF THIS DEVICE. THE DOCTOR RESEARCHED FURTHER AND FOUND OUT CLEARLY FDA HAS APPROVED THIS PRODUCT ONLY FOR PROFESSIONAL USE. THIS IS DESPITE THE FACT THAT (B)(6) IS EASILY ADVERTISING AND SELLING THE PRODUCT. WITH FURTHER RESEARCH WE CAME TO KNOW - THAT DEVICE CREATES DEEP TISSUE HEATING AND CAN LEAD TO PERMANENT DAMAGE IN UNBORN BABIES INCLUDING PERMANENT BRAIN DAMAGE AND LOSS OF HEARING. WE WOULD NEED FDA IMMEDIATE HELP AND ATTENTION TO THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841990 SONOLINE SYSTEM IMAGING KNG DAGAMMA INC. B

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention