BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTIMATE ROSE VAGINAL DILATORS

    MDR report key: 16701015 · Received April 6, 2023

    Report

    Report Number
    MW5116435
    Event Type
    Other
    Date Received
    April 6, 2023
    Report Date
    April 4, 2023
    Manufacturer
    SHENZHEN ENOVART TECHNOLOGY CO., LTD
    Product Code
    HDX
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPROPER LABELING AND MARKETING FOR PRODUCT. INTIMATE ROSE DILATORS ARE BEING TAUTED AS THE ONLY FDA REGISTERED DILATOR FOR VAGINAL DILATION. HOWEVER, ON THE FDA SITE, THIS PRODUCT IS ONLY APPROVED FOR CERVICAL DILATION WHICH THIS IN NO WAY DOES, AND IS CAUSING CONFUSION AMONG PATIENTS AND PRACTITIONERS. SEE WEBSITE HTTPS://WWW.INTIMATEROSE.COM/COLLECTIONS/VAGINAL-DILATORS SEE FDA REPORT HTTPS://FDA.REPORT/COMPANY/PLUS-EV-HOLDINGS-INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518531 INTIMATE ROSE VAGINAL DILATORS DILATOR, VAGINAL HDX SHENZHEN ENOVART TECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown