BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7641544 · Received June 27, 2018

    Report

    Report Number
    3003701733-2018-00033
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    May 30, 2018
    Report Date
    September 5, 2018
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS RECEIVED AND CORRECTIONS/ADDITIONS WERE MADE: A VISUAL INSPECTION OF 10 COMPANION SAMPLES OF UBK SLEEK SUPER WAS CONDUCTED. THE VISUAL EXAMINATION DID NOT OBSERVE ANY PRODUCT DEFECTS OR ABNORMALITIES. CORRECTIONS: BRAND NAME - CHANGED FROM U BY KOTEX CLICK TO U BY KOTEX SLEEK. MANUFACTURER NAME - CHANGED FROM STAFF TO NUEVO NOGALES. MANUFACTURING INFORMATION - CHANGED FROM STAFF TO NUEVO NOGALES. PMA/510K - CHANGED FROM K113036 TO K112635. DEVICE EVALUATED BY MANUFACTURER - CHANGE FROM "NO" AND "NOT RETURNED TO MANUFACTURER" TO "YES". (B)(4). MODEL #: ADDED SUPER. LOT #: ADDED NN733813B2338. UDI #: (B)(4). DEVICE AVAILABILITY - ADDED "YES", RETURNED TO MANUFACTURER "CHECKED", DATE RETURNED ADDED "08-08-2018". DEVICE MANUFACTURER DATE - ADDED 12-04-2017. MANUFACTURER NARRATIVE - ADDED "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".

    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 CADENCE OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, ALL COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY BASIS. 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 BY EMAIL THAT DURING REMOVAL A TAMPON CAME APART INSIDE OF HER. THIS OCCURRED WITH ONE TAMPON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482695 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER NN733813B2338

    Patients

    Seq Age Sex Outcome Treatment
    1