BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7137319 · Received December 21, 2017

    Report

    Report Number
    3011109575-2017-00111
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 21, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998375
    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) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. A CLUSTER ASSESSMENT FOUND NO SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, 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 CANADA. THE CONSUMER STATED BY EMAIL THAT DURING REMOVAL A TAMPON CAME APART AND PIECES REMAINED INSIDE. THIS OCCURRED WITH THREE TAMPONS. THERE HAVE BEEN TWO ATTEMPTS (06 DEC 2017, 13 DEC 2017) TO CONTACT THE CONSUMER FOR MORE INFORMATION, BUT WE HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916457 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER NN726913A 00036000998375

    Patients

    Seq Age Sex Outcome Treatment
    1