BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB

    MDR report key: 4153025 · Received October 8, 2014

    Report

    Report Number
    3007303617-2014-00021
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    QINGDAO P&B CO., LTD.
    Product Code
    HEB
    PMA / PMN Number
    PK113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS LOT CODE WAS NOT PROVIDED BY THE CONSUMER. 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. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT WHEN REMOVING THE TAMPON, ONLY HALF OF THE PLEDGET CAME OUT. SHE WAS ABLE TO REMOVE THE REMAINING PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632149 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB QINGDAO P&B CO., LTD. SUPER

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR