BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23465334 · Received November 4, 2025

    Report

    Report Number
    3011109575-2025-00083
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 4, 2025
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    PMA / PMN Number
    K223749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRIMARY DI AND PRODUCTION IDENTIFIER OF LOT NUMBER WERE NOT AVAILABLE FROM THE REPORTER. AN ATTEMPT WAS MADE TO OBTAIN MORE INFORMATION FOR THIS SOCIAL MEDIA COMPLAINT, INCLUDING THE REPORTER'S NAME AND ADDRESS. WITH NO MEANS TO DETERMINE THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED.

    Description of Event or Problem · 0

    REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A REGULAR ABSORBENCY TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS OR THE NEED FOR MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834881 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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female