BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9467009 · Received December 13, 2019

    Report

    Report Number
    3011109575-2019-01615
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    May 13, 2019
    Report Date
    December 13, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998368
    PMA / PMN Number
    K112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE VERIFIED THAT THE REPORTED LOT NUMBER IS PART OF THE U BY KOTEX SLEEK TAMPONS, REGULAR ABSORBENCY 2018 RECALL. NO ADDITIONAL ANOMALIES DURING THE MANUFACTURE OF THE PRODUCT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION WERE DISCOVERED DURING A REVIEW CONDUCTED OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS AT THE MANUFACTURING FACILITY IN (B)(4).

    Description of Event or Problem · 1

    CONSUMER'S MOTHER REPORTED THAT THE TAMPON STRING FELL OFF PRIOR TO USE. HOWEVER, DAUGHTER SAW GYNECOLOGIST. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261807 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN634213A 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1