BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT

    MDR report key: 810635 · Received January 26, 2007

    Report

    Report Number
    MW1041761
    Event Type
    Other
    Date Received
    January 26, 2007
    Date of Event
    January 21, 2007
    Report Date
    January 26, 2007
    Manufacturer
    GLAXOSMITHKINE/CNS, INC.
    Product Code
    LWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED A BREATHE RIGHT NASAL STRIP, THE TAN LARGE SIZE, TO SLEEP BETTER. WHEN I REMOVED THE STRIP IN THE MORNING, IT TORE OFF SEVERAL LAYERS OF SKIN. IT HAS BEEN OOZING AND BLEEDING EVER SINCE. I HAVE NO SKIN IRRITATIONS OR ALLERGIES TO LATEX OR ADHESIVES. I HAVE USED CLEAR REST EASY NASAL STRIPS FROM WALGREEN'S WITH NO PROBLEMS, BUT MY NOSE IS NOW A MESS FROM THIS PRODUCT. THERE WERE NO WARNINGS ON THE PACKAGE THAT THE NASAL STRIPS COULD BE SO HARMFUL WHEN REMOVED SLOWLY ACCORDING TO THE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKINE/CNS, INC. LARGE TAN *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other