BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7781258 · Received August 14, 2018

    Report

    Report Number
    3003701733-2018-00046
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 1, 2018
    Report Date
    August 14, 2018
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND RECORDS CAN BE PERFORMED. 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

    THE CONSUMER STATED BY EMAIL THAT DURING REMOVAL A TAMPON CAME APART AND PIECES REMAINED INSIDE. THERE HAVE BEEN THREE ATTEMPTS (17 JUL 2018, 25 JUL 2018, AND 01 AUG 2018) TO CONTACT THE CONSUMER FOR MORE INFORMATION, BUT WE HAVE NOT BEEN SUCCESSFUL. IF WE BECOME AWARE OF RELATED ADVERSE EFFECT(S) ON THE CONSUMER'S HEALTH, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622324 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1