BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4120893 · Received September 26, 2014

    Report

    Report Number
    9611594-2014-00086
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    PK113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. A VISUAL INSPECTION WAS PERFORMED ON (B)(4) COMPANION SAMPLES. THE VISUAL INSPECTION DID NOT OBSERVE ANY PRODUCT DEFECTS OR ABNORMALITIES. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HER TAMPON CAME APART IN TWO PIECES UPON REMOVAL AND ONE PIECE REMAINED INSIDE OF HER. SHE WAS ABLE TO REMOVE THE REMAINING PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601893 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB AVENT S. DE R.L. DE C.V. REGULAR AA332301B

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR