BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE ULTRASOUND COUPLANT TRANSMISSION FETAL DOPPLER GEL

    MDR report key: 12475898 · Received September 14, 2021

    Report

    Report Number
    MW5103968
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    May 16, 2021
    Report Date
    September 12, 2021
    Product Code
    MUI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED "2 BOTTLES OF BLUE ULTRASOUND GEL FOR MY FETAL DOPPLER" BACK IN (B)(6) 2021 AND USED IT OFTEN. ON (B)(6) 2021, I NOTICED MY SKIN WAS BECOMING TERRIBLY ITCHY AND OPEN SORES WHICH APPEARED INFECTED BEGAN TO SHOW UP ON MY ARMS AND TOP OF THIGHS. NOW BEING (B)(6) 2021, I AM NOW ALMOST 8 MONTHS PREGNANT, AND THE OPEN SORES STILL COVER MOST OF MY BODY. THEY TEND TO ITCH MORE FREQUENTLY AT NIGHT, AND HAVE RESISTED MULTIPLE FUNGAL AND ANTIBACTERIAL TREATMENTS. (B)(6) LTD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369194 BLUE ULTRASOUND COUPLANT TRANSMISSION FETAL DOPPLER GEL MEDIA, COUPLING, ULTRASOUND MUI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Disability