BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8503970 · Received April 11, 2019

    Report

    Report Number
    3011109575-2019-01132
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 11, 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
    AZ, US
    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 REPORTED ISSUE.

    Description of Event or Problem · 1

    CONSUMER'S BOYFRIEND CALLED ON HER BEHALF TO REPORT THAT SHE HAD A HOSPITAL STAY WHERE SHE HAD TOXIC SHOCK SYNDROME DUE TO TAMPON PIECES THAT WERE STUCK INSIDE HER BODY FROM THE TAMPONS FALLING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297848 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V. SUPER NN822513B0211 00036000998375

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L