BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS - REGULAR ABSORBENCY

    MDR report key: 600803 · Received May 10, 2005

    Report

    Report Number
    2381757-2005-00007
    Event Type
    Other
    Date Received
    May 10, 2005
    Date of Event
    April 14, 2005
    Report Date
    May 10, 2005
    Manufacturer
    KIMBERLY-CLARK CORP.
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2005 ALLEGING THAT THE PATIENT EXPERIENCED AN INFECTION AS A RESULT OF PINCHING OF THE VAGINAL WALL. THE PATIENT ALLEGEDLY EXPERIENCED A RASH WITH SWELLING IN THE VAGINAL AREA AND A WELT ON THEIR LEFT ARM. THE PATIENT VISITED THEIR GYNECOLOGIST AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS - REGULAR ABSORBENCY UNSCENTED MENSTRUAL TAMPONS HEB KIMBERLY-CLARK CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O