BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8652032 · Received May 29, 2019

    Report

    Report Number
    3011109575-2019-01273
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 29, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998375
    PMA / PMN Number
    K112635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    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

    CONSUMER REPORTED THE TAMPONS BECAME UNCOMFORTABLE AND PAINFUL TO USE. VAGINAL PAIN PERSISTED WHEN TAMPON WAS REMOVED. SHE EXPERIENCED SWEATING, HOT FLASHES, INTERMITTENT BLEEDING/SPOTTING, CONSTANT VAGINAL PAIN FROM MILD TO SEVERE, PAIN WITH URINATION AND VAGINAL DISCHARGE. SYMPTOMS STARTED TWO YEARS AGO AND PROGRESSIVELY WORSENED EVEN AFTER SHE STOPPED TAMPON USE. SHE WENT TO HER PCP SEVERAL TIMES AND HAD TESTS DONE. SHE HAD AN ABNORMAL RESULT FROM PAP TEST WHICH RESULTED NON-CANCEROUS, A BIOPSY OF HER CERVIX AND A TRANS-VAGINAL ULTRASOUND WHICH WERE BOTH NORMAL. SHE WAS REFERRED TO AN OBGYN AND HAD EXPLORATORY LAPAROSCOPIC OUTPATIENT SURGERY. OBGYN FOUND ENDOMETRIOSIS, ADHESIONS, AND SCAR TISSUE. SHE HAD FEVER POST-SURGERY. PAIN MEDICATIONS WERE PRESCRIBED POST-SURGERY. SHE STILL HAD SWEATING AND HOT FLASHES BUT THEY HAD GOTTEN BETTER. SHE TOOK AZITHROMYCIN IN CASE THERE WAS AN INFECTION. ALL TESTS CAME BACK NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443308 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER 00036000998375

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other