BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT CUP

    MDR report key: 7344626 · Received March 15, 2018

    Report

    Report Number
    MW5075894
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 24, 2018
    Report Date
    February 26, 2018
    Manufacturer
    THE FLEX COMPANY
    Product Code
    HHE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE SOFT CUP FOR THE FIRST TIME AND SOMEHOW IT GOT STUCK BEHIND MY CERVIX. I HAD TO VISIT THE EMERGENCY ROOM. THE DR THAT GOT IT OUT SAID THERE WAS NO WAY I COULD HAVE GOTTEN IT OUT AND HE EVEN HAD DIFFICULTIES GETTING IT OUT. I EMAILED THE COMPANY AND ALL THEY SAID IS WE ARE SORRY, THAT'S ALL. PURCHASE DATE: (B)(6) 2018. DOCUMENT NUMBER: (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183404 SOFT CUP SOFT CUP HHE THE FLEX COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1