BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 5811963 · Received July 21, 2016

    Report

    Report Number
    3011112444-2016-00011
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 22, 2016
    Report Date
    July 21, 2016
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V (AA)
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 EVENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND PIECES REMAINED INSIDE OF HER. SHE INDICATED THAT THE EVENT OCCURRED ON SEVEN DIFFERENT OCCASIONS. SHE WAS ABLE TO REMOVE THE REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464937 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V (AA) SUPER PLUS AA529301A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR