BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11966661 · Received June 9, 2021

    Report

    Report Number
    3011109575-2021-00201
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 9, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.

    Description of Event or Problem · 1

    CONSUMER REPORTED HER FRIEND USED A TAMPON AND THE PLEDGET FELL APART. SHE REPORTED HER FRIEND WAS FINE. NO FURTHER INFORMATION WAS PROVIDED REGARDING CONSUMER'S USE OF THE PRODUCT AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862275 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V

    Patients

    Seq Age Sex Outcome Treatment
    1