BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOLINE B - BABY HEARTBEAT TRACKER- BABYDOPPLER

    MDR report key: 10718653 · Received October 21, 2020

    Report

    Report Number
    MW5097397
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 20, 2020
    Manufacturer
    CONTEC MEDICAL SYSTEM CO., LTD.
    Product Code
    KNG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM PREGNANT AT WEEK (B)(6). I RECEIVED A GIFT FORM MY SISTER WHO PURCHASED A PRODUCT IN US WHICH WAS SHIPPED FROM A COMPANY IN US. THIS WAS RECEIVED IN 3-4 BUSINESS DAYS. THE SELLER PROMOTES AND RECOMMENDS USING THIS DEVICE AT HOME FOR BRINGING PEACE OF MIND TO PREGNANT LADIES. THE DEVICE IS CALLED "FETAL DOPPLER" WHICH IS A HAND HELD ULTRASOUND DEVICE ENABLING TO HEAR BABY HEARTBEAT. I USED THE DEVICE AT HOME AND AT FIRST I WAS UNABLE TO SPOT THE HEARTBEAT SO I TRIED IT THE DAY AFTER ALSO. THEN I STARTED FEELING A BAD CRAMP IN MY STOMACH AND SEVERE BLEEDING. I RUSHED TO MY DOCTOR AND TO ALL MY SURPRISE MY OB INFORMED ME THAT THIS DEVICE COULD BE POTENTIALLY HARMFUL AND NOT SOLD OTC. I WAS VERY MUCH WORRIED AND EMOTIONALLY CHALLENGED AS I NEEDED TO FIGURE OUT IS SUCH A WARNING EXISTING ON THE SELLER SIDE ABOUT THE USE AND MORE IMPORTANTLY THE FACT THAT THE DEVICE WOULD NEED TO BE USED UNDER THE SUPERVISION OF A MEDICAL PRACTITIONER. NOT ONLY I FOUND ANYTHING ON SELLER SITE ELABORATING THAT BUT ALSO I OBSERVED SO MANY PEOPLE WHO HAVE USED THIS DEVICE WITHOUT ANY PROPER KNOWLEDGE. WHEN I DID FURTHER RESEARCH I CAME TO KNOW THAT THERE IS A DIRECTION IN FEDERAL REGISTER THAT FETAL DOPPLERS ARE NOT AT ALL MEANT FOR HOME USE. THEY ARE TO BE USED BY GUIDANCE ONLY. EVEN DURING THE CURRENT PANDEMIC THERE IS A MANDATE UNDER THE TITLE OF "ENFORCEMENT POLICY FOR NON-INVASIVE FETAL AND MATERNAL MONITORING DEVICES USED TO SUPPORT PATIENT MONITORING DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY- GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF" IDENTIFIED WITH THE DOCKET NUMBER FDA-2020-D-1138. IN THIS DOCUMENT IT STATES THAT EVEN IN THE TIME OF PANDEMIC THE DEVICE SHOULD BE CLEARLY MARKET AS ONLY USED WITH PRESCRIPTION. WE HAVE CONTACTED THE SELLER AND HAVE BEEN RUDELY TREATED. THIS IS A SERIOUS HEALTH HAZARD TO PUBLIC HEALTH WHICH IS DOING UNNOTICED. THE SELLER PORTAL AND CLAIMS ARE ALL AVAILABLE AT: (B)(6) THANK YOU FOR YOUR ATTENTION TO THIS NOTE. HOPE THIS WILL PREVENT OTHER EXPECTING COUPLES TO GO THROUGH THE DRAMA THAT WE EXPERIENCED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174072 SONOLINE B - BABY HEARTBEAT TRACKER- BABYDOPPLER MONITOR, ULTRASONIC, FETAL KNG CONTEC MEDICAL SYSTEM CO., LTD. SONOLINE B

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other