BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTIMINA LILY CUP COMPACT A

    MDR report key: 9818436 · Received March 10, 2020

    Report

    Report Number
    MW5093673
    Event Type
    Injury
    Date Received
    March 10, 2020
    Date of Event
    February 25, 2020
    Report Date
    March 8, 2020
    Manufacturer
    LELO INC
    Product Code
    HHE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED INTIMINA LILY CUP MENSTRUAL PERIOD COLLECTION DEVICE. (I BOUGHT THE CORRECT FIT AND HAVE USED INTRAVAGINAL BIRTH CONTROL DEVICES PRIOR SO I AM FAMILIAR WITH USE OF INTRAVAGINAL DEVICES). THIS CUP CREATED SO MUCH SUCTION / VACUUM ON THE CERVIX THAT I WAS UNABLE TO REMOVE ON MY OWN. I HAVE TRIED VALSALVA MANEUVERS AND SQUATTING TO TRY TO GET IT OUT BUT ENDED UP HAVING A PHYSICIAN REMOVE IT USING A SPECULUM AND RING FORCEPS, VERY PAINFUL. NO LONGER HAVE THE PRODUCT THE DR THREW IT IN THE BIOHAZARD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277529 INTIMINA LILY CUP COMPACT A CUP, MENSTRUAL HHE LELO INC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R