BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BU KOTEX CLICK

    MDR report key: 3040186 · Received April 8, 2013

    Report

    Report Number
    9611594-2013-00044
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 14, 2013
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED AND THE PRODUCT WAS FOUND TO BE MADE TO SPECIFICATION. NO ANOMALIES WERE RECORDED TO COINCIDE WITH THE REPORTED EVENT. 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 DAUGHTER USED TWO TAMPONS AND THEY CAME APART UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144151 U BU KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. AA217601B0509

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR