BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 7009263 · Received November 8, 2017

    Report

    Report Number
    3011109575-2017-00090
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Report Date
    November 8, 2017
    Manufacturer
    K-C AFC MANUFACTURING, S. DE. R.L. DE C.V.
    Product Code
    HEB
    UDI-DI
    00036000998399
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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. THE REVIEW FOUND OCCURRENCES OF 1 TYPE OF DEFECT, IN SUBASSEMBLY LOTS USED AS RAW MATERIAL FOR THE REPORTED FINISHED PRODUCT LOT, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. HOWEVER, THESE WERE WITHIN THE ACCEPTABLE QUALITY LIMIT (AQL) PER OUR FINISHED PRODUCT SPECIFICATIONS. ACTIONS TAKEN: A NOTIFICATION OF THIS MATTER WAS SENT BY THE PLANT QUALITY ENGINEER TO THE PLANT PRODUCTION PERSONNEL FOR AWARENESS. THE FINISHED PRODUCT INSPECTION DID NOT FIND ANY DEFECTS FOR PLEDGETS, OR MISSING/SEPARATED/PULLED OUT STRINGS. A CLUSTER ASSESSMENT FOUND NO SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT.

    Description of Event or Problem · 1

    THE CONSUMER STATED BY EMAIL THAT DURING REMOVAL A TAMPON CAME APART AND THE OUTER COVER REMAINED INSIDE. THERE HAVE BEEN 3 ATTEMPTS (10/16/2017, 10/23/2017 AND 10/30/2017) TO CONTACT CONSUMER FOR MORE INFORMATION BUT WE HAVE NOT BEEN SUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790447 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE. R.L. DE C.V. REGULAR NN718213C 00036000998399

    Patients

    Seq Age Sex Outcome Treatment
    1