BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4840919 · Received June 12, 2015

    Report

    Report Number
    2381757-2015-00024
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 16, 2015
    Manufacturer
    KIMBERLY-CLARK CORPORATION - CONWAY MILL
    Product Code
    HEB
    PMA / PMN Number
    PK112635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCUMENT AND RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. DOCUMENTATION ASSESSED INCLUDES: MANUFACTURING, QUALITY AUDIT, PRODUCTION, RAW MATERIAL AND DEVICE HISTORY RECORDS. THIS ASSESSMENT FOUND NO ANOMALIES THAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE; THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. COMPLAINT SAMPLE WAS NOT RETURNED THEREFORE A PRODUCT EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND ANALYSIS.

    Description of Event or Problem · 1

    WHEN THE CONSUMER PULLED THE TAMPONS OUT, THE COTTON WAS FRAYED AND COMING APART. CONSUMER STATED SHE GOT AN INFECTION AND NEEDED TO TAKE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385620 U BY KOTEX SLEEK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB KIMBERLY-CLARK CORPORATION - CONWAY MILL REGULAR AC504266X1704

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR