BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7126547 · Received December 18, 2017

    Report

    Report Number
    3011109575-2017-00108
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 18, 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) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. A CLUSTER ASSESSMENT FOUND 1 SIMILAR/RELATED COMPLAINTS FOR THE REPORTED LOT. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN. 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 STATES THAT A TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE. SHE STATES SHE REMOVED SIX PIECES OF THE TAMPON, BUT IS UNSURE IF PIECES REMAIN. SHE IS PLANNING ON SEEKING MEDICAL ASSISTANCE. TWO ADDITIONAL ATTEMPTS ((B)(6) 2017) TO CONTACT THE CONSUMER FOR MORE INFORMATION, BUT WE HAVE NOT BEEN SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904982 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN713113A1116 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR