BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORA MENSTRUAL DISC

    MDR report key: 13306978 · Received January 19, 2022

    Report

    Report Number
    MW5106811
    Event Type
    Injury
    Date Received
    January 19, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 14, 2022
    Manufacturer
    CORA / LYV LIFE INC.
    Product Code
    HHE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TODAY I WOKE UP TO EMPTY MY CORA MENSTRUAL DISC, IT HAD SLIPPED SO FAR BACK I COULD BARELY REACH IT. NOT TO MENTION IT IS SLIPPERY SO I COULDN'T EVEN WIGGLE A FINGER UNDER IT TO BREAK THE SEAL. I ENDED UP IN THE EMERGENCY ROOM, 2 NURSES TRIED FOR 15 MINUTES AND COULD NOT RELEASE IT, IT IS SO SLIPPERY THEY COULD NOT GRASP IT WITH FORCEPS AND IT SLID EVEN FURTHER BACK. THEY HAD TO CALL A GYNECOLOGIST TO THE ER FOR HELP. I HAVE BEEN HERE SEVERAL HOURS AND IT IS STILL STUCK INSIDE MY VAGINA. I AM LIVID. I HAVE USED SEVERAL OTHER DISCS AND NEVER HAD AN ISSUE. THIS DISC IS TOO SLIPPERY AND TOO FIRM. THE LITTLE LIP TO SUPPOSEDLY BE ABLE TO PULL IT OUT NEVER HAS WORKED EITHER BECAUSE THE MATERIAL IS FAR TOO SLIPPERY. THIS PRODUCT IS DANGEROUS AND SHOULD BE RECALLED. THIS WAS TRAUMATIZING, I HAVE USED OTHER DISCS FOR A COUPLE YEARS AND HAD NO PROBLEMS BEING ABLE TO REMOVE THEM. THIS ONE IS A DANGER TO WOMEN, AND SHOULD BE PULLED FROM SHELVES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849234 CORA MENSTRUAL DISC CUP, MENSTRUAL HHE CORA / LYV LIFE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention HUMALOG| LEVOTHYROXINE | METFORMIN