BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX

    MDR report key: 3093174 · Received May 4, 2013

    Report

    Report Number
    3007303617-2013-00006
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    QINGDAO P&B CO., LTD.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT HER TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE WAS ABLE TO REMOVE THE REMAINING PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195704 U BY KOTEX TAMPON HEB QINGDAO P&B CO., LTD. SUPER PB2270AAB0429

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR