BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOONCUP®/MCUK®

    MDR report key: 8878472 · Received August 9, 2019

    Report

    Report Number
    3009117944-2019-00002
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 9, 2019
    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 CONTACTED MOONCUP LTD ON (B)(6) 2019 VIA THE SOCIAL MEDIA PLATFORM (B)(6) TO MAKE US AWARE OF DAMAGE TO THE RIGHT SIDE OF HER PELVIC FLOOR WHEN REMOVING THE CUP. THE CUSTOMER ALSO DESCRIBES PAIN IN HER BLADDER ON THE RIGHT SIDE WHEN HER BLADDER FILLS. THE CUSTOMER STATES THAT THIS FIRST OCCURRED IN (B)(6) 2016 WITH ONLY BRIEF PERIODS OF RESPITE SINCE WITH THE SYMPTOMS RETURNING IN (B)(6) 2019. THE CUSTOMER REPORTS THAT SHE HAS BEEN UNDER THE CARE OF A PHYSIOTHERAPIST, GYNAECOLOGIST AND GENERAL PRACTITIONER (GP) SINCE THE ONSET OF THE SYMPTOMS. MOONCUP LTD HAVE ASKED THE CUSTOMER TO CONTACT THE MOONCUP LTD ADVICE SERVICE DIRECTLY SO THAT FURTHER INVESTIGATION CAN BE UNDERTAKEN HOWEVER AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT BEEN BACK IN CONTACT. AS SUCH IT HAS NOT BEEN POSSIBLE TO CONFIRM THAT THE MENSTRUAL CUP IN QUESTION IS A MOONCUP® OR IF THE CUSTOMER HAS BEEN GIVEN A SPECIFIC DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674662 MOONCUP®/MCUK® MENSTRUAL CUP HHE MOONCUP LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability