BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3953274 · Received July 23, 2014

    Report

    Report Number
    9611594-2014-00050
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431604 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. SUPER AA404101B

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR