BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11983064 · Received June 11, 2021

    Report

    Report Number
    3011109575-2021-00205
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515893
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    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 REPORTED THE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE DEVELOPED YEAST INFECTION LIKE SYMPTOMS WITH ITCHINESS AND SWELLING OF THE VAGINAL AREA. SHE SELF-TREATED WITH A VINEGAR DOUCHE AND AZO. HER SYMPTOMS WERE NOT IMPROVING SO SHE CALLED AND SPOKE WITH HER HEALTHCARE PROVIDER. THEY PRESCRIBED BORIC ACID SUPPOSITORIES AND HER SYMPTOMS IMPROVED. SHE DID NOT SEEK ANY ADDITIONAL MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878177 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN105713C0740 00036000515893

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR