BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8905940 · Received August 19, 2019

    Report

    Report Number
    3003701733-2019-00571
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 19, 2019
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A BRAND NAME, 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.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED INDICATED THE CONSUMER REPORTED SHE USED MEDICATED DOUCHE AND YEAST INFECTION MEDICATIONS AND EVENTUALLY HAD TO HAVE A MINOR VAGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702172 U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention