BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2823704 · Received January 10, 2011

    Report

    Report Number
    3007303617-2011-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    QINGDAO P&B CO. LTD
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT CODE WAS NOT PROVIDED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER DID NOT RETURN PRODUCT FOR EVAL.

    Description of Event or Problem · 1

    CONSUMER WAS REMOVING A TAMPON AND THE TAMPON CAME APART INSIDE HER. CONSUMER INDICATED SOME OF THE PIECES REMAINED INSIDE AFTER REMOVAL OF THE TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB QINGDAO P&B CO. LTD REGULAR

    Patients

    Seq Age Sex Outcome Treatment
    1