BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIP

    MDR report key: 1914505 · Received November 30, 2010

    Report

    Report Number
    3004486989-2010-00002
    Event Type
    Other
    Date Received
    November 30, 2010
    Report Date
    November 30, 2010
    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 AND DESCRIBED THE OCCURRENCE OF ADDICTION IN A (B)(6) FEMALE PT WHO REC'D BREATHE RIGHT NASAL STRIPS FOR A BREATHING PROBLEM. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS. AT AN UNK TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED ADDICTION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. CONSUMER STATED "I AM ADDICTED TO THESE NOSE STRIPS AND IT'S AMAZING HOW MUCH EASIER IT IS FOR ME TO BREATHE." 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 STRIP NASAL STRIP LWF GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other