BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17415086 · Received July 28, 2023

    Report

    Report Number
    3011109575-2023-00182
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 28, 2023
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    PMA / PMN Number
    K172118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT CODE PROVIDED WAS FOR A PRODUCT THAT CONTAINED MULTIPLE ABSORBENCIES. THE CONSUMER DID NOT PROVIDE AN ABSORBENCY, THEREFORE WE ARE UNABLE TO PROVIDE A UDI NUMBER OR MODEL. REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND SUPPORTING QUALITY RECORDS CONFIRMED NO ANOMALIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE MALFUNCTION. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURE.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT PRIOR TO USE OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING WAS MISSING. SHE DID NOT USE THE TAMPONS AND SHE DISCARDED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325852 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V NN302413B1918

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female