BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 6958700 · Received October 18, 2017

    Report

    Report Number
    3011109575-2017-00079
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 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
    NM, 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 TWO OCCURRENCES OF A DEFECT, IN SUBASSEMBLY LOTS USED AS RAW MATERIAL FOR THE REPORTED FINISHED PRODUCT LOT, THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. HOWEVER, THESE DEFECTS DID NOT EXCEED THE ALLOWABLE NUMBER OF FAILURES PER OUR PROCEDURE. THE FINISHED PRODUCT INSPECTION DID NOT FIND ANY DEFECTS FOR PLEDGETS, OR MISSING/SEPARATED/PULLED OUT STRINGS. A CLUSTER ASSESSMENT FOUND 1 SIMILAR OR RELATED COMPLAINT 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

    THE CONSUMER STATED THAT UPON REMOVAL, THE INNER PORTION OF THE TAMPON PULLED AWAY FROM THE COVER, LEAVING THE INNER LAYER IN THE VAGINAL CANAL. SHE IS PLANNING TO VISIT HER DOCTOR TO ENSURE ALL PIECES ARE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737448 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN711313D 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR