BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 3131777 · Received May 29, 2013

    Report

    Report Number
    9611594-2013-00058
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. A DOCUMENT AND RECORDS REVIEW WAS PERFORMED OF THE REPORTED LOT. THE DEVICE HISTORY RECORDS REVIEW INCLUDES: QUALITY AUDIT, PRODUCTION, AND RAW MATERIALS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. INCIDENT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE REPORTED ISSUE. PRODUCTION HISTORY RECORDS REVIEW SHOWED THAT THE PRODUCT WAS PRODUCED ACCORDING TO SPECIFICATIONS AND REQUIREMENTS. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATION WILL BE INITIATED AND CORRECTIVE ACTIONS TAKEN IF INDICATED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT TWO TAMPONS CONTAINED A BLACK SUBSTANCE WHICH APPEARED TO BE MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234771 U BY KOTEX SLEEK TAMPON HEB AVENT S. DE R.L. DE C.V. SUPER AA200501B

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR