BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEVA BABY FETAL DOPPLER

    MDR report key: 17756330 · Received September 14, 2023

    Report

    Report Number
    MW5145685
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 12, 2023
    Manufacturer
    SHENZHEN MERICONN TECHNOLOGY CO.,LTD
    Product Code
    KNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/10/2023 FOR REPORT NUMBER MW5145685 TO CORRECT THE PROCODE.

    Description of Event or Problem · 0

    HI THERE, I'M A 28-YEAR-OLD PREGNANT WOMAN FROM TEXAS. MY HUSBAND AND I WERE OVER THE MOON ABOUT EXPECTING OUR FIRST CHILD, AND I WAS AT THE DELICATE 14-WEEK MARK OF MY PREGNANCY. ONE DAY, WHILE SCROLLING THROUGH BABY PRODUCTS ON TARGET.COM, I CAME ACROSS THIS INTRIGUING PRODUCT THAT PROMISED TO HELP BONDING WITH MY BABY. GIVEN MY RECENT FAMILY TRAGEDY - MY SISTER HAD SUFFERED A MISCARRIAGE - I WAS LOOKING FOR ANYTHING THAT COULD BRING ME SOME PEACE OF MIND. I DECIDED TO GIVE IT A SHOT AND PURCHASED THE PRODUCT FROM THE TARGET.COM WEBSITE. IT CLAIMED TO HELP ME HEAR MY BABY'S HEARTBEAT, WHICH SOUNDED LIKE A GODSEND. THE FIRST TIME I USED IT, I STRUGGLED TO DETECT ANYTHING, BUT AFTER ABOUT 20 MINUTES OF CONTINUOUSLY TRYING, I FINALLY HEARD THE PRECIOUS SOUND. I AM NOT SURE WHAT HAPPENED, MAYBE BECAUSE I WAS USING IT FOR A LONG PERIOD OF TIME BUT ALL OF A SUDDEN THE DEVICE HEATED UP AND NEARLY BURNED ME WHEN I WAS TRYING TO USE IT. THE WAND ITSELF ALMOST LEFT A MARK ON MY STOMACH. I FELT DEVASTATED AND BLAMED MYSELF FOR NOT DOING ENOUGH RESEARCH. HOW COULD I HAVE KNOWN? THIS PRODUCT WAS READILY AVAILABLE, EVEN FROM A TRUSTED SOURCE LIKE TARGET.COM. IT EVEN HAD RECOMMENDATIONS AND OVER 2000 REVIEWS ON THE TARGET.COM WEBSITE. IT WAS HARD TO BELIEVE THAT SOMETHING SO EASILY ACCESSIBLE COULD POSE A THREAT TO MY BODY OR BABY. UPON FURTHER RESEARCH I HAD NOTICED THAT THIS IS A PRESCRIPTION ONLY MEDICAL DEVICE AND WAS WONDERING HOW IT IS SOLD DIRECTLY TO CONSUMERS ON TARGET.COM VIA THIS LINK HTTPS://WWW.TARGET.COM/P/NEEVA-BABY-FETAL-DOPPLER/-/A-89087721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767988 NEEVA BABY FETAL DOPPLER MONITOR, ULTRASONIC, FETAL KNG SHENZHEN MERICONN TECHNOLOGY CO.,LTD FD200
    295130 NEEVA BABY FETAL DOPPLER MONITOR, ULTRASONIC, FETAL KNG SHENZHEN MERICONN TECHNOLOGY CO.,LTD FD200

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Congenital Anomaly| O B COMPLEX.| IRON.