BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19228425 · Received May 2, 2024

    Report

    Report Number
    3011109575-2024-00038
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 2, 2024
    Manufacturer
    K-C AFC MANUFACTURING, S. DE R.L. DE C.V
    Product Code
    HEB
    UDI-DI
    00036000515862
    PMA / PMN Number
    K223749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 SHE WORE A TAMPON FOR 8 HOURS AND UPON REMOVAL ON (B)(6) 2024, THE STRING SEPARATED FROM THE PLEDGET. SHE ATTEMPTED TO REMOVE THE PLEDGET AND A PIECE OF PLEDGET BROKE OFF AND REMAINED INSIDE OF HER. SHE WAS UNABLE TO REMOVE THE REMAINING PIECE AND ON THE SAME DAY, (B)(6) 2024, SHE WENT TO THE EMERGENCY ROOM FOR REMOVAL. THE CONSUMER REPORTED EXPERIENCING A FEVER, ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE REPORTED THAT THE EMERGENCY ROOM PROVIDER FELT THAT SHE HAD THE START OF TSS, PRESCRIBED HER AMOXICILLIN AND ADMINISTERED A DOSE OF AMOXICILLIN IN THE EMERGENCY ROOM. SHE REPORTS SHE WAS INSTRUCTED TO RETURN TO THE EMERGENCY ROOM IF HER SYMPTOMS WORSENED. AS OF HER REPORTING ON (B)(6) 2024, THE CONSUMER STILL HAD A FEVER AND SOME ABDOMINAL CRAMPING, BUT WAS UNSURE IF IT WAS RELATED TO HER PERIOD. 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
    409983 U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB TAMPON, MENSTRUAL, UNSCENTED HEB K-C AFC MANUFACTURING, S. DE R.L. DE C.V REGULAR NN329113B0436 00036000515862

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention