BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17247698 · Received July 3, 2023

    Report

    Report Number
    3011109575-2023-00168
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 19, 2023
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515831
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. A VAGINAL EXAM WITH CONSUMER'S OBGYN CONFIRMED THAT NO PLEDGET PIECES WERE INSIDE OF HER VAGINAL CAVITY.

    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

    FOLLOW-UP REPORT 4 OF 4. ADDITIONAL INFORMATION RECEIVED INDICATES THE CONSUMER VISITED HER OBGYN AND A VAGINAL EXAM CONFIRMED THAT NO PIECES OF TAMPON PLEDGET WERE INSIDE OF HER VAGINAL CAVITY.

    Description of Event or Problem · 0

    REPORT 4 OF 4. CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255431 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN303013B 00036000515831

    Patients

    Seq Age Sex Outcome Treatment
    1 Female