BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 2496688 · Received March 16, 2012

    Report

    Report Number
    3004486989-2012-00004
    Event Type
    Other
    Date Received
    March 16, 2012
    Report Date
    March 15, 2012
    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 LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER VIA EMAIL AND DESCRIBED THE OCCURRENCE OF STOPPED BREATHING IN A MALE PT WHO REC'D BREATHE RIGHT NASAL STRIPS FOR SLEEPING AID. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS (TOPICAL). AT AN UNK TIME AFTER STARTING BREATH RIGHT NASAL STRIPS, THE PT EXPERIENCED STOPPED BREATHING. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENT WAS RESOLVED. AE INFO REC'D VIA EMAIL (B)(6) 2012: "HELLO, I JUST BOUGHT A PACK OF BREATHE RIGHT AND WHEN I TRIED THEM ON, THEY WERE GREAT UNTIL SUDDENLY, I STOPPED BREATHING. LUCKILY I COULD GET IT OFF IN TIME BUT I DON'T KNOW HOW BUT FOR SOME REASON, BREATHE RIGHT DOESN'T ALLOW ME TO BREATHE. IT IS THE COMPLETE OPPOSITE OF WHAT IT IS SUPPOSED TO DO. I AM NOT PLEASED WITH YOUR PRODUCT. I AM NOT SURE IF I WILL USE THIS TO HELP ME SLEEP." F/U IS ONGOING TO DETERMINE WHETHER THE CONSUMER EXPERIENCED A FEELING OF SUFFOCATION OR ACTUALLY STOPPED BREATHING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other