BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 4113872 · Received September 24, 2014

    Report

    Report Number
    9611594-2014-00083
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    PK113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER STATED TAMPON FELL APART INSIDE HER WHEN SHE WENT TO REMOVE THE TAMPON. SHE STATES THE SHE PULLED THE TAMPON STRING AND OUTER COVERING CAME OUT AND SHE HAD PIECES STUCK IN HER VAGINA. THE CONSUMER WENT TO HER HEALTH CARE PROVIDER TO GET IT REMOVED AND WAS PRESCRIBED AN ANTIBIOTIC. THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593494 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB AVENT S. DE R.L. DE C.V. REGULAR AA412201B

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR