BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8885850 · Received August 12, 2019

    Report

    Report Number
    3011109575-2019-01358
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    June 4, 2017
    Report Date
    August 12, 2019
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998375
    PMA / PMN Number
    K112635
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE (MALFUNCTION OR REPORTED ISSUE).

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT UPON REMOVAL THE TAMPON STRING BROKE, LEAVING THE PLEDGET INSIDE. SHE SOUGHT MEDICAL ASSISTANCE FOR THE REMOVAL OF THE TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677061 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V SUPER NN705713C0841 00036000998375

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other