BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 2845038 · Received November 7, 2012

    Report

    Report Number
    3004486989-2012-00010
    Event Type
    Other
    Date Received
    November 7, 2012
    Report Date
    November 6, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA A MARKETING RESEARCH STUDY ((B)(6)) AND DESCRIBED THE OCCURRENCE OF INFECTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED BREATH RIGHT NASAL STRIPS FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS (TOPICAL). AT UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED INFECTION. THE PATIENT WAS HOSPITALISED FOR 4 DAYS. THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAVENOUS ANTIBIOTICS. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 3004486989-2012-00010. BREATHE RIGHT NASAL STRIPS ARE MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT, NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization