BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8718155 · Received June 20, 2019

    Report

    Report Number
    3011109575-2019-01300
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    March 1, 2019
    Report Date
    July 8, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: REPORT TYPE, OUTCOMES ATTRIBUTED TO ADVERSE EVENT , THIS IS A FOLLOW UP REPORT TO ADD ADVERSE EVENT DUE TO ALLEGED TSS, FOLLOW-UP 1, TYPE OF REPORTABLE EVENT, FOLLOW-UP TYPE, PATIENT CODE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT TO ADD ADVERSE EVENT DUE TO ALLEGED TSS.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION.

    Description of Event or Problem · 1

    CONSUMER'S MOTHER REPORTED ON BEHALF OF HER DAUGHTER THAT A TAMPON FELL APART UPON REMOVAL AND SHE HAD TO REMOVE IT WITH TWEEZERS. SHE TOOK HER TO A PHYSICIAN'S ASSISTANT AT HER PEDIATRICIAN AND THEY COULD NOT PERFORM A VAGINAL EXAM DUE TO HER AGE. HER DAUGHTER WAS PUT ON DEPO SHOTS DURING THE APPOINTMENT TO PREVENT HER FROM HAVING FURTHER PERIODS. HER DAUGHTER EXPERIENCED HEADACHES, NAUSEA, FEVER, DIZZINESS AND STOMACH CRAMPING AFTER THE TAMPON FELL APART AND SHE WAS CONCERNED ABOUT TSS. HER DAUGHTER IS STILL EXPERIENCING BAD HEADACHES, NAUSEA, DIZZINESS AND TROUBLE SLEEPING. NO LONGER EXPERIENCING CRAMPING. HER DAUGHTER ALSO HAD DEVELOPED A LUMP AROUND HER BREAST AND HER MOTHER CONSULTED A NURSE OVER THE PHONE. THE LUMP IS A SWOLLEN LYMPH NODE. SHE WAS PRESCRIBED NAUSEA MEDICATION AND AN ULTRASOUND FOR THE LUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510927 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR AA333301B2358 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other