BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23290022 · Received October 15, 2025

    Report

    Report Number
    3011109575-2025-00068
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 14, 2025
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515817
    PMA / PMN Number
    K223749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECORDS DEMONSTRATE THAT THE FINISHED PRODUCT WAS PRODUCED ACCORDING TO SPECIFICATIONS, MET ALL QUALITY ACCEPTANCE CRITERIA FOR PRODUCT RELEASE, AND QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED.

    Description of Event or Problem · 0

    CONSUMER REPORTED VIA EMAIL THAT UPON OPENING AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS, THE STRING WAS MISSING PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790852 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V KOTEX TAMPONS NN423713C1523 00036000515817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female