BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6927143 · Received October 7, 2017

    Report

    Report Number
    3011109575-2017-00075
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 10, 2017
    Report Date
    October 6, 2017
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) DID NOT SHOW ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. RECORDS ALSO DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED. A LOT ASSESSMENT FOUND NO OTHER SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A WEEKLY BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, ALL COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT UPON REMOVAL THE TAMPON PULLED APART LEAVING PIECES BEHIND. THIS OCCURRED WITH THREE OR FOUR TAMPONS. SHE IS CONFIDENT THAT SHE WAS ABLE TO REMOVE THE REMAINING PIECES. THE CONSUMER DID NOT SEEK MEDICAL ASSISTANCE. ON (B)(6) THE CONSUMER REPORTED NO RELATED PROBLEMS OR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707067 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN713213D 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR