BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8921940 · Received August 22, 2019

    Report

    Report Number
    3003701733-2019-00705
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 22, 2019
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A BRAND NAME, 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.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED INDICATED THE CONSUMER REPORTED THE TAMPON FELL APART WHILE INSIDE OF HER. SHE EXPERIENCED YEAST COMING OUT WITH TAMPON REMOVAL AND SEVERE DISCHARGE. SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH VAGINAL IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717476 U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION SUPER

    Patients

    Seq Age Sex Outcome Treatment
    1