BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17287818 · Received July 10, 2023

    Report

    Report Number
    3011109575-2023-00175
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 10, 2023
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000998399
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURER LOT CODE WAS NOT PROVIDED. WITH NO MEANS TO ASCERTAIN THE MANUFACTURER/ASSET LINE AND DAY OF PRODUCTION, NO FURTHER INVESTIGATION ON DOCUMENTS AND SUPPORTING RECORDS CAN BE PERFORMED. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. ALSO, AS IT WAS REMOVED, THE STRING SEPARATED FROM THE PLEDGET AND REMAINED IN ONE PIECE. SHE MANUALLY REMOVED PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE HAD A DOCTOR'S EXAM THE FOLLOWING DAY WHICH CONFIRMED NO PIECES REMAINED INSIDE OF HER. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185756 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR 00036000998399

    Patients

    Seq Age Sex Outcome Treatment
    1 Female