BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX CLICK TAMPONS SUPER

    MDR report key: 1830908 · Received September 7, 2010

    Report

    Report Number
    9611594-2010-00028
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 8, 2010
    Report Date
    September 7, 2010
    Manufacturer
    AVENT S DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER INSERTED THE TAMPON AND THE CLEAR APPLICATOR TUBE REMAINED WITH THE TAMPON INSIDE HER VAGINA AND SHE RECEIVED A MINOR CUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other