BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17277329 · Received July 7, 2023

    Report

    Report Number
    3011109575-2023-00177
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 7, 2023
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515862
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECORDS DEMONSTRATE THAT QUALITY SYSTEM PROCEDURES WERE CORRECTLY FOLLOWED AND THE FINISHED PRODUCT MET ALL QUALITY RELEASE CRITERIA AND SPECIFICATIONS WERE WITHIN ALLOWABLE LIMITS PRIOR TO RELEASE. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURE.

    Description of Event or Problem · 0

    REPORT 2 OF 2. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614216 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN232313C 00036000515862

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female