BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALWAYS

    MDR report key: 375710 · Received January 31, 2002

    Report

    Report Number
    MW4003185
    Event Type
    Malfunction
    Date Received
    January 31, 2002
    Date of Event
    December 1, 2001
    Report Date
    January 31, 2002
    Manufacturer
    PROCTER & GAMBLE CO
    Product Code
    HHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY HAD AN UNUSUAL EXPERIENCE WHEN OPENING AN "ALWAYS" THIN PAD (SANITARY NAPKIN). WHEN THEY OPENED THE PRODUCT LAST EVENING. THEY SAID IT EXHIBITED A VERY STRONG, TOXIC-LIKE ODOR AND THAT IT CONTAINED POWDER. CONSUMER SAID IT APPEARS THAT SOMEONE INTENTIONALLY PUT THE SUBSTANCE IN THE PRODUCT. CONSUMER PURCHASED THE PRODUCT LAST MONTH. ONE BOX CONTAINS TWO PACKAGES OF 36 INDIVIDUALLY PACKAGED PADS. THEY STATED THAT ONE PACKAGE HAS 18 REMAINING AND THE OTHER HAS 21 REMAINING. CONSUMER HAS BEEN USING THIS BRAND OF PRODUCT FOR YEARS AND THEY HAVE NEVER ENCOUNTERED ANYTHING LIKE THIS. CONSUMER CONTACTED THE MFR AND THEY TOLD THEM IT COULD BE A MANUFACTURING PROBLEM. THEY ASKED CONSUMER TO MAIL THE PRODUCT TO THEM. CONSUMER SAID THEY ARE CONCERNED ABOUT TOXINS AND ARE WORRIED THEY WILL NOT TELL THEM WHAT IS IN THE PRODUCT. CONSUMER WOULD LIKE TO HAVE IT TESTED. REFERRED TO 911. CONSUMER SAID IT WAS NOT AN EMERGENCY, THEY WERE JUST CONCERNED ABOUT THEIR HEALTH. ADDITIONALLY, THE PRODUCT HAS BEEN STORED IN THE BATHROOM AND CONSUMER IS WORRIED ABOUT THE HEALTH OF THEIR CHILDREN. THE COMPLAINANT SAID THEY DEVELOPED A HEADACHE WITHIN 10 MINUTES OF OPENING THE PRODUCT. IT LASTED UNTIL THEY WENT TO BED AT 11:00 PM. THEY SAID THEY WERE FINE THIS MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALWAYS ULTRA THIN PADS HHL PROCTER & GAMBLE CO NA 13204786650224

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO