BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7836521 · Received August 31, 2018

    Report

    Report Number
    3011109575-2018-00113
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    June 1, 2018
    Report Date
    September 18, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998399
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A VALID 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.

    Additional Manufacturer Narrative · 1

    BRAND NAME: UPDATED FROM CLICK TO SLEEK ADDITIONAL DEVICE INFORMATION - MODEL # : REMOVED REGULAR. ADDITIONAL DEVICE INFORMATION - UDI # - (B)(4). ADDITIONAL DEVICE INFORMATION - LOT # - ADDED NN804313B. PREMARKET IDENTIFICATION - UPDATED FROM K113036 TO K112635. ADDITIONAL INFORMATION: ADDITIONAL DEVICE INFORMATION - LOT # - ADDED NN804313B. DEVICE MANUFACTURE DATE: ADDED FEB 12, 2018. (B)(4). THE DEVICE HISTORY RECORD (DHR) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. 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 (B)(6). THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE INDICATED THE EVENT HAPPENED WITH FOUR TAMPONS. SHE WAS ABLE TO REMOVE THE REMAINING PIECES. SHE DID NOT SEEK MEDICAL ASSISTANCE, AND HAS NO PLANS TO DO SO. CONSUMER REPORTED SHE WAS FINE, NO FURTHER FOLLOW UPS ARE TASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679285 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN804313B 00036000998399

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR