BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 525711 · Received May 19, 2004

    Report

    Report Number
    2381757-2004-00002
    Event Type
    Other
    Date Received
    May 19, 2004
    Date of Event
    March 29, 2004
    Report Date
    May 19, 2004
    Manufacturer
    KIMBERLY-CLARK CORP./CONSUMER PRODUCT MILLS
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORP REC'D NOTICE IN 2004 ALLEGING THAT THE PT HAD A BAD ODOR AND PAIN URINATING. ACCORDING TO THE COMPLAINT, THE PT VISITED A DOCTOR AND ALLEGES THAT A PORTION OF THE PLEDGET WAS LEFT IN THEIR VAGINA. THE PT ALLEGES THIS WAS THE CAUSE OF THE VAGINAL INFECTION.

    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