BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U BY KOTEX SLEEK

    MDR report key: 7129197 · Received December 19, 2017

    Report

    Report Number
    3011109575-2017-00109
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 24, 2017
    Report Date
    December 19, 2017
    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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) AND QUALITY RECORDS WERE REVIEWED. THESE DOCUMENTS DEMONSTRATE THAT PROCEDURES WERE CORRECTLY FOLLOWED. A CLUSTER ASSESSMENT FOUND NO SIMILAR OR RELATED COMPLAINTS FOR THE REPORTED LOT. COMPLAINTS WHICH ARE SERIOUS IN NATURE ARE REVIEWED ON A REGULAR BASIS OR FOR DUE CAUSE TO PROVIDE VISIBILITY AND ESCALATION. IN ADDITION, COMPLAINTS ARE ALSO MONITORED FOR TRENDING ON A MONTHLY CADENCE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS A NON-US EVENT. THE EVENT OCCURRED IN (B)(6). THE CONSUMER STATED THAT A TAMPON CAME APART UPON REMOVAL AND TAMPON PIECES REMAINED INSIDE OF HER. SHE INDICATED THAT THE EVENT OCCURRED WITH FIVE OR SIX TAMPONS USED. SHE IS CONFIDENT SHE WAS ABLE TO REMOVE THE REMAINING PIECES AND DID NOT NEED TO SEEK MEDICAL ASSISTANCE. SHE ALSO STATED SHE EXPERIENCED VAGINAL PAIN DURING USE AND WHILE REMOVING THE TAMPON. HOWEVER, DURING THE LAST FOLLOW UP, SHE HAD NO MORE VAGINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908411 U BY KOTEX SLEEK TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN707713D2140 00036000998368

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR