BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17404614 · Received July 27, 2023

    Report

    Report Number
    3011109575-2023-00184
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 5, 2023
    Report Date
    July 27, 2023
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000534450
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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

    CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY WHICH SHE REPORTED HURT AT THE TIME BUT IT HAS RESOLVED. SHE DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323424 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN227214A1000 00036000534450

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female