BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX CLICK

    MDR report key: 3093145 · Received May 4, 2013

    Report

    Report Number
    9611594-2013-00049
    Event Type
    Malfunction
    Date Received
    May 4, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED OF THE REPORTED LOT AA035201A. THE DEVICE HISTORY RECORDS REVIEW INCLUDES: QUALITY AUDIT, PRODUCTION, AND RAW MATERIALS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE. PRODUCTION HISTORY OF LOT CODE REFERRED SHOWS DEVICE WAS MANUFACTURED WITHIN SPECIFICATION REQUIREMENTS. EVEN THOUGH SAMPLE WAS NOT RECEIVED FOR EVALUATION, IN ORDER TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE, (B)(4) WAS ISSUED FOR FURTHER ASSESSMENT IN ORDER TO IMPLEMENT AN ACTION PLAN AND CORRECTIVE ACTIONS FOR THE REPORTED FAILURE MODE. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AND CORRECTIVE ACTION TAKEN IF INDICATED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT MULTIPLE TAMPONS CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE INDICATED AS A RESULT, SHE EXPERIENCED HOT FLASHES, DARK VAGINAL DISCHARGE, FOUL ODOR AND FATIGUE. SHE VISITED HER GYNECOLOGIST ON (B)(6) 2013 AND THE GYNECOLOGIST REMOVED A CLUMP OF FIBERS THAT WERE ABOUT THE SIZE OF A SILVER DOLLAR. SHE INDICATED THAT HER SYMPTOMS SUBSIDED AFTER HER DOCTOR VISIT. SHE HAS SINCE DISCONTINUED USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195698 U BY KOTEX CLICK TAMPON HEB AVENT S. DE R.L. DE C.V. REGULAR AA035201A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR