BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOONCUP/MCUK

    MDR report key: 11197669 · Received January 19, 2021

    Report

    Report Number
    3009117944-2021-00001
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MOONCUP LTD
    Product Code
    HHE
    PMA / PMN Number
    K060852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER GOT IN TOUCH WITH MOONCUP LTD TO INFORM US THAT WHEN USING THE MOONCUP MENSTRUAL CUP FOR THE FIRST TIME OVER TWO DAYS OF THEIR PERIOD, THEY EXPERIENCED SIGNIFICANT PRESSURE ON THEIR BLADDER. THEY ALSO EXPERIENCED DIFFICULTY AND DISCOMFORT WHEN REMOVING THE MOONCUP® WITH THE STEM PRESSING ON THEIR VAGINAL OPENING UNCOMFORTABLY. SINCE USING THE CUP, THEY REPORT EXPERIENCING ONGOING DISCOMFORT, PAIN AFTER URINATING AND A CONSTANT DULL ACHE TO THE URETHRA. THEY SPOKE TO THEIR NURSE WHO SUGGESTED THEY MAY HAVE INTERNAL BRUISING. FOLLOWING A PERIOD OF AROUND 6 WEEKS, THE CUSTOMER HAS HAD MULTIPLE APPOINTMENTS WITH DOCTORS. THE CUSTOMER HAS BEEN TREATED FOR CYSTITIS AND STATES THAT THE INFECTION HAS PASSED BUT REPORTS THAT THE INFLAMMATION AND PRESSURE ON THEIR BLADDER CONTINUES. THEY HAVE UNDERGONE A BLOOD TEST AND ARE AWAITING AN ULTRASOUND SCAN (DELAYED DUE TO THE ONGOING COVID-19 PANDEMIC). THE CUSTOMER REPORTS WAKING UP EVERY NIGHT FOR WEEKS WITH THE URGE TO URINATE THOUGH BEING UNABLE TO DO SO. THE CUSTOMER REPORTS THAT THEY HAVE BEEN LEFT STRESSED AND SLEEP-DEPRIVED BY THIS SITUATION AND THAT THEY HAVE NO PRIOR HISTORY OF URINARY TRACT OR VAGINAL INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89623 MOONCUP/MCUK MENSTRUAL CUP HHE MOONCUP LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other