BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 5831045 · Received July 28, 2016

    Report

    Report Number
    3011112444-2016-00013
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 28, 2016
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V (AA)
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    CONSUMER STATED SEVERAL TIMES WHEN REMOVING THE TAMPONS THEY ELONGATED AND LEFT MATERIAL BEHIND. SHE IS CONFIDENT THE MATERIAL WAS REMOVED, NO MEDICAL CARE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481198 U BY KOTEX CLICK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V (AA) REGULAR AA523701A1129

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR