BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11885046 · Received May 26, 2021

    Report

    Report Number
    3011109575-2021-00162
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515824
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO REMOVE THE REMAINING PIECES OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783096 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER PLUS NN104813A1001 00036000515824

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR