BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U BY KOTEX CLICK TAMPONS

    MDR report key: 1780896 · Received July 30, 2010

    Report

    Report Number
    9611594-2010-00015
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 30, 2010
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    HEB
    PMA / PMN Number
    K091749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE CONSUMER DID NOT PROVIDE LOT CODE INFO. SAMPLES WERE NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER STATED ON THE 4TH DAY OF HER CYCLE SHE REMOVED A TAMPON AND IT CAME OUT RATHER SHREDDED, LIKE THE TOP COVER CAME OFF THE TAMPON AND FIBERS REMAINED WITHIN. ON THE 5TH DAY OF HER CYCLE, SHE DEVELOPED NAUSEA, HIGH FEVER, SEVERE ABDOMINAL CRAMPS, AND BACK PAIN. SHE WENT TO THE ER AND LEFT WITHOUT TREATMENT DUE TO THE BUSINESS OF THE ER. ON THE 6TH DAY OF HER CYCLE SHE PASSED A PIECE OF BLOOD SOAKED COTTON THE SIZE OF HALF OF A COTTON BALL. HER GYNECOLOGIST DID AN ULTRASOUND TO MAKE SURE IT WAS NOT A MISCARRIAGE. THE GYNECOLOGIST INDICATED THIS WAS THE START OF TOXIC SHOCK SYNDROME (TSS) AND PUT HER ON AUGMENTIN. THE CONSUMER IS ALSO TAKING IBUPROFEN FOR ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U BY KOTEX CLICK TAMPONS HEB - UNSCENTED MENSTRUAL TAMPON HEB AVENT S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention