BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 8503971 · Received April 11, 2019

    Report

    Report Number
    3011109575-2019-01130
    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
    00036000998368
    PMA / PMN Number
    K112635
    Removal / Correction Number
    3003701733
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE VERIFIED THAT THE REPORTED LOT NUMBER IS PART OF THE (B)(6) 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)(6).

    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
    297849 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V. REGULAR NN816813D0105 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L