BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1881448 · Received October 19, 2010

    Report

    Report Number
    3008144662-2010-00016
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 19, 2010
    Manufacturer
    QINGDAO P&B., LTD.
    Product Code
    HEB
    PMA / PMN Number
    K896994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. CONSUMER DID NOT RETURN PRODUCT SAMPLES FOR EVALUATION.

    Description of Event or Problem · 1

    THE CONSUMER INDICATED THE TAMPON CAME APART UPON REMOVAL AND THE SMALL PIECE OF PLASTIC APPLICATOR CAME APART.

    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., LTD. REGULAR ABSORBENCY PB0160AAA1510

    Patients

    Seq Age Sex Outcome Treatment
    1