BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5757951 · Received June 29, 2016

    Report

    Report Number
    3011112444-2016-00010
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V (NUEVO NOGALES
    Product Code
    HEB
    PMA / PMN Number
    PK113036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THIS IS A NON US EVENT. CONSUMER STATED SHE HAD 2 INCIDENTS OF A PLEDGET UNRAVELING AND FALLING APART. THEY BOTH HAVE BEEN UBK SUPER PLUS CLICK TAMPONS. THE FIRST TOOK PLACE IN APRIL. SHE HAS NO LOT INFORMATION OR PRODUCT FROM THAT PACKAGE REMAINING. THE SECOND INCIDENT OCCURRED (B)(6) 2016. BOTH TIMES SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET. THERE WAS NO INJURY OR MEDICAL CARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413667 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V (NUEVO NOGALES SUPER PLUS AA534701B

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR