BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4130346 · Received September 30, 2014

    Report

    Report Number
    2381757-2014-00068
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    PK112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD IS UNDER REVIEW. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS. CONSUMER HAD NOT RETURNED UNUSED PRODUCT FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE PLEDGET BROKE INTO PIECES INSIDE HER, NOT SURE IF ALL PIECES REMOVED. CONSUMER WENT TO HER HEALTHCARE PROVIDER. CONSUMER STATED THAT EVERYTHING WAS REMOVED ALREADY. SHE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608268 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR AC416066X0254

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR