BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTES SECURITY TAMPONS

    MDR report key: 407094 · Received July 26, 2002

    Report

    Report Number
    2381757-2002-00001
    Event Type
    Other
    Date Received
    July 26, 2002
    Date of Event
    February 19, 2002
    Report Date
    June 27, 2002
    Manufacturer
    KIMBERLY-CLARK CORP./ COMSUMER PRODUCT MILL
    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 CORPORATION RECEIVED NOTICE ON 2002 ALLEGING THAT ON OR ABOUT 02/2002, THE PATIENT CLAIMED TO HAVE A URINARY TRACT INFECTION, CRAMPS AND DIARRHEA. PT ALLEGES THAT A PORTION OF THE PLEDGET LEFT IN PT'S VAGINA WAS THE CAUSE FOR PT'S URNIARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTES SECURITY TAMPONS UNSCENTED MENSTRUAL TAMPONS HEB KIMBERLY-CLARK CORP./ COMSUMER PRODUCT MILL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other