BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORA MENSTRUAL DISC

    MDR report key: 18274504 · Received December 5, 2023

    Report

    Report Number
    MW5148854
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 2, 2023
    Manufacturer
    LYV LIFE INC.
    Product Code
    HHE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED THE CORA PERFECT FIT MENSTRUAL DISC FROM AMAZON. USED IT FOR THE FIRST TIME AND I WAS UNABLE TO REMOVE ON MY OWN. I TRIED SEVERAL TIMES AND, AFTER 24 HOURS, I WENT TO THE DOCTOR TO GET ASSISTANCE REMOVING THIS DISC. THIS PRODUCT SHOULD HAVE ADDITIONAL FEATURES TO MAKE IT EASIER TO REMOVE. TAMPON REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258290 CORA MENSTRUAL DISC CUP, MENSTRUAL HHE LYV LIFE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention