BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUNE MENSTRUAL CUP

    MDR report key: 10712212 · Received October 20, 2020

    Report

    Report Number
    MW5097352
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    October 13, 2020
    Manufacturer
    XI'AN FURUIZE BIOTECHNOLOGY CO., LTD.
    Product Code
    HHE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SUSPECTED UTERINE PROLAPSE; TROUBLE REACHING AND REMOVING MENSTRUAL CUP LEAD TO UTERUS BEING PULLED. DEVICE INCLUDED NO INSTRUCTIONS ON REMOVAL AND DEPTH OF CUPS SITTING POSITION DID NOT ALLOW FOR REMOVAL WITHOUT PULLING. SUFFERING FROM UNUSUAL CONTINUED CRAMPING 7 DAYS AFTER START OF PERIOD AND APPROX 3 DAYS AFTER END. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167828 JUNE MENSTRUAL CUP CUP, MENSTRUAL HHE XI'AN FURUIZE BIOTECHNOLOGY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other