BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX SECURITY TAMPONS

    MDR report key: 534976 · Received July 19, 2004

    Report

    Report Number
    2381757-2004-00003
    Event Type
    Other
    Date Received
    July 19, 2004
    Date of Event
    July 8, 2004
    Report Date
    July 19, 2004
    Manufacturer
    KIMBERLY-CLARK CORP., CONSUMER PRODUCT MILLS
    Product Code
    HEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORP RECEIVED NOTICE IN 2004 ALLEGING THAT THE PT HAD AN INFECTION. ACCORDING TO THE COMPLAINT, THE PT VISITED THE HOSP AND AFTER HAVING BLOOD DRAWN WAS TOLD THAT THEY HAVE AN INFECTION. THE PT ALLEGED THAT PIECES OF THE TAMPON WERE LEFT INSIDE THEM AND WAS THE CAUSE OF THE INFECTION. THE PT STATED THE HOSP DID NOT REMOVE THE TAMPON.

    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