BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 2011728 · Received March 2, 2011

    Report

    Report Number
    3004486989-2011-00003
    Event Type
    Other
    Date Received
    March 2, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BREATHE RIGHT NASAL STRIPS ARE MANUFACTURED IN (B)(4), IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SORES AT APPLICATION IN A (B)(6) FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT PRODUCT INCLUDED BREATHE RIGHT NASAL STRIPS ADVANCED. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS TAN (TOPICAL). AT AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED A SORE AT APPLICATION SITE THAT TURNED INTO CANCER. THIS OCCURRED NINE YEARS PRIOR TO REPORTING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. THE PATIENT WAS TREATED BY A PHYSICIAN WHO REMOVED THE CANCER. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. SUBSEQUENTLY, THE PATIENT USED BREATHE RIGHT NASAL STRIPS ADVANCED. AT AN UNKNOWN TIME AFTER USING THIS VARIANT, THE PATIENT EXPERIENCED APPLICATION SITE REDNESS DESCRIBED AS "LITTLE RED SPOTS ON MY NOSE" THAT WERE CAUSED BY REMOVAL OF BREATHE RIGHT ADVANCED. THE PATIENT DID NOT USE WARM WATER TO REMOVE THE STRIPS DEVICE MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIPS BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA 2489T14491

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other