BEUDAMED
    FDA Adverse Event Other Summary report: N

    KOTEX ULTRATHIN PADS WITH WINGS

    MDR report key: 613839 · Received June 14, 2005

    Report

    Report Number
    2381757-2005-00009
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    May 16, 2005
    Report Date
    June 14, 2005
    Manufacturer
    KIMBERLY CLARK CORPORATION
    Product Code
    HHD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    KIMBERLY CLARK CORPORATION RECEIVED NOTICE IN 2005 ALLEGING THAT THE PATIENT EXPERIENCED IRRITATION WITH REDNESS/DRYNESS/BUMPS. THE PATIENT ALLEGES THAT THEIR DOCTOR TOLD THEM THE IRRITATION WAS DUE TO THEIR USE OF MENSTRUAL PADS. THE PATIENT STATED THAT THEY WERE USING KOTEX ULTRATHIN PADS WITH WINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOTEX ULTRATHIN PADS WITH WINGS MENSTRUAL PADS HHD KIMBERLY CLARK CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other