BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2241534 · Received August 29, 2011

    Report

    Report Number
    3007303617-2011-00065
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 21, 2011
    Manufacturer
    QINGDAO P&B CO, LTD
    Product Code
    HEB
    PMA / PMN Number
    K103311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 HAD NOT RETURNED UNUSED PRODUCT FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CONSUMER INDICATED A TAMPON CAME APART DURING REMOVAL AND PIECES REMAINED INSIDE HER. A PHYSICIAN REMOVED THE REMAINING PIECES. THE CONSUMER DEVELOPED A YEAST AND BACTERIAL INFECTION AND WAS TREATED FOR THE INFECTION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1