BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11858640 · Received May 20, 2021

    Report

    Report Number
    3011109575-2021-00150
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 20, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998399
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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

    THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER IS A REGISTERED NURSE WHO REPORTED SHE WORE A TAMPON FOR FIVE TO SIX HOURS AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET PIECES AND DID NOT SEEK ADDITIONAL MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752302 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR 00036000998399

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR