BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17287711 · Received July 10, 2023

    Report

    Report Number
    3011109575-2023-00179
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 10, 2023
    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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MODEL, UDI OR MANUFACTURER LOT CODE WERE NOT PROVIDED. WITH NO MEANS TO DETERMINE THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURE.

    Description of Event or Problem · 0

    CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING SEPARATED FROM THE PLEDGET. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655008 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 Female