BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 561339 · Received December 23, 2004

    Report

    Report Number
    2381757-2004-00006
    Event Type
    Other
    Date Received
    December 23, 2004
    Date of Event
    December 16, 2004
    Report Date
    December 23, 2004
    Manufacturer
    KIMBERLY CLARK CORP., CONSUMER PRODUCT MILLS
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN ALLEGING THAT A PT HAD AN ALLERGIC REACTION. ACCORDING TO THE COMPLAINT, THE PT VISITED THE ALLERGIST OFFICE AND PT'S LABIA WAS RED AND SWOLLEN. THE DR ALLEGED THAT LABIA BECOME IRRIATED FROM TAMPON STRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPON HEB KIMBERLY CLARK CORP., CONSUMER PRODUCT MILLS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other