BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 6514853 · Received April 22, 2017

    Report

    Report Number
    3011109575-2017-00014
    Event Type
    Malfunction
    Date Received
    April 22, 2017
    Report Date
    May 23, 2017
    Manufacturer
    K-C AFC MANUFACTURING S. DE RL DE CV
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THIS IS A NON US EVENT. A CONSUMER CALLED IN EXPLAINING THAT SHE AND HER DAUGHTERS HAVE HAD NUMEROUS ISSUES WITH THE U BY (B)(6) SLEEK TAMPONS. THE TAMPONS HAVE BEEN FALLING APART OVER THE LAST MONTH AND LEAVING PIECES OF TAMPONS IN THE VAGINA WHICH WERE REMOVED MANUALLY. THIS MDR IS FOR REPORTERS (B)(6) DAUGHTER AND U BY K SLEEK REGULAR ABSORBENCY. DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A WEEKLY CADENCE OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. COMPLAINTS ARE ALSO MONITORED FOR TRENDING DURING OUR PERSONAL CARE COMPLAINT REVIEW PROCESS ON A MONTHLY CADENCE WHERE A CROSS-FUNCTIONAL TEAM MEETS TO REVIEW COMPLAINT TRENDS NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS FOR HER (B)(6) DAUGHTER AND U BY K SLEEK SUPER PLUS ABSORBENCY. AN ASSESSMENT OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT CODE WAS COMPLETED BASED ON THE TIME PROVIDED AND THE TIME PERIOD USED FOR STATISTICAL SAMPLING FOR PRODUCT RELEASE. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A CLUSTER ASSESSMENT FOUND 0 SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A WEEKLY CADENCE OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. COMPLAINTS ARE ALSO MONITORED FOR TRENDING DURING OUR PERSONAL CARE COMPLAINT REVIEW PROCESS ON A MONTHLY CADENCE WHERE A CROSS-FUNCTIONAL TEAM MEETS TO REVIEW COMPLAINT TRENDS. A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT COULD NOT BE CONFIRMED. SINCE NO ROOT CAUSE WAS FOUND, THERE IS NO CORRECTIVE OR PREVENTIVE ACTION THAT CAN BE TAKEN AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE AL FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A NON US EVENT. THIS EVENT OCCURRED IN (B)(6). A CONSUMER CALLED IN EXPLAINING THAT SHE AND HER DAUGHTERS HAVE HAD NUMEROUS ISSUES WITH THE U BY (B)(6) SLEEK TAMPONS. THE TAMPONS HAVE BEEN FALLING APART OVER THE LAST MONTH AND LEAVING PIECES OF TAMPONS IN THE VAGINA. THEY HAVE REMOVED THE PIECES MANUALLY AND HAVE NOT REQUIRED ANY MEDICAL CARE. NONE OF THE TAMPONS APPEARED DIFFERENT PRIOR TO USE. THIS MDR IS FOR HER (B)(6) DAUGHTER AND U BY K SLEEK REGULAR ABSORBENCY.

    Description of Event or Problem · 1

    THIS MDR IS FOR HER (B)(6) DAUGHTER AND U BY K SLEEK SUPER-PLUS ABSORBENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296109 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING S. DE RL DE CV SUPER-PLUS NN631501A0716 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR