BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3232343 · Received December 11, 2012

    Report

    Report Number
    9611594-2012-00151
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 10, 2012
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CONSUMER INDICATED THAT HER TAMPON UNRAVELED UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE FEELS THAT SHE WAS ABLE TO MOVE THE REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPON HEB AVENT SA DE R.L. DE C.V. SUPER PLUS AA128501A1038

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR