BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECOVUE ULTRASOUND GEL

    MDR report key: 23887650 · Received December 23, 2025

    Report

    Report Number
    MW5181151
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    July 10, 2025
    Report Date
    December 18, 2025
    Manufacturer
    HR PHARMACEUTICALS, INC. / D/B/A HR HEALTHCARE
    Product Code
    MUI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6), A MEMBER OF (B)(6) IN (B)(6), EXPERIENCED 21 EVENTS INVOLVING 20 PATIENTS WITH THE USE OF ECOVUE ULTRASOUND GEL (MANUFACTURER: HR PHARMACEUTICALS, INC.) DURING OBSTETRICAL ULTRASOUNDS (US) OVER A 6-MONTH PERIOD (B)(6) 2025). OF THESE, 13 OCCURRED IN THE AREA OF MATERNAL FETAL MEDICINE (MFM) AND THE REMAINING 8 OCCURRED IN LABOR & DELIVERY/ POST-PARTUM. THE REACTIONS RANGED FROM MILD ITCHY RED RASH/ HIVES TO EXTREME REDNESS COVERING THE ENTIRE ABDOMEN WITH AREAS OF EXCORIATION AND PAINFUL TO TOUCH. SOME REACTIONS WERE IMMEDIATE AND OTHERS WERE DELAYED. TREATMENT RANGED FROM NO TREATMENT/CLEANSING THE ABDOMEN TO TOPICAL STEROIDS AND ORAL ANTIHISTAMINES. NO PERMANENT HARM RESULTED FROM THESE EVENTS. THE PRODUCT MANUFACTURER HAS BEEN NOTIFIED ABOUT THESE EVENTS. NO TESTING DONE BY HOSPITAL. PATIENT: 1943, 2033, 1840, 1994. DEVICE: 2682. REFERENCE REPORTS:MW5181141, MW5181142, MW5181143, MW5181144, MW5181145, MW5181146, MW5181147, MW5181148, MW5181149, MW5181150, MW5181152, MW5181153, MW5181154, MW5181155, MW5181156, MW5181157, MW5181158, MW5181159, MW5181160, MW5181161.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476933 ECOVUE ULTRASOUND GEL MEDIA, COUPLING, ULTRASOUND MUI HR PHARMACEUTICALS, INC. / D/B/A HR HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other