BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 8312027 · Received February 5, 2019

    Report

    Report Number
    MW5083789
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Report Date
    February 2, 2019
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    KOTEX CLICK TAMPON LITERALLY BROKE WHILE INSIDE MY VAGINA. WHEN ATTEMPTING TO REMOVE SAID TAMPON THE [INVALID] COMPLETELY (AND SCARILY, EFFORTLESSLY) BROKE OFF, LEAVING THE [INVALID] IN MY HAND AND THE TAMPON INSIDE MY VAGINA. THANK GOD I DIDN¿T HAVE ANYWHERE TO BE. THANK GOD I WAS IN THE COMFORT OF MY OWN HOME. AND HOLY THANK GOD, THAT AFTER 60 PANICKED MINUTES OF PRAYING TO EVERY GOD THAT EVER EXISTED I WAS ABLE TO WRESTLE THE DAMN THING OUT OF MY BODY. THIS IS UNACCEPTABLE. NOT OK. DATE THE PERSON FIRST STARTED USING THE PRODUCT: (B)(6) 2018. DATE THE PERSON STOPPED USING THE PRODUCT: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101676 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR