BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 2040004 · Received March 9, 2011

    Report

    Report Number
    9611594-2011-00030
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 25, 2011
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IN REVIEW. 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 AND TAMPON PLASTIC PIECES REMAINED IN HER VAGINA. THE CONSUMER AND HER HUSBAND COULD NOT REMOVE IT. THE HOTEL PHYSICIAN SENT THE CONSUMER TO A LOCAL HOSPITAL WHERE THEY WERE ABLE TO REMOVE THE TAMPON AND PLASTIC. SHE RETURNED TO HOSPITAL 4 DAYS LATER FOR AN INJECTION AND TOOK A PRESCRIPTION FOR 7 DAYS. THIS IS A NON-US EVENT. THE MALFUNCTION OCCURRED IN (B)(6) TO A (B)(6) CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT SA DE R.L. DE C.V. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1