BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT KID'S NASAL STRIPS

    MDR report key: 2579983 · Received May 15, 2012

    Report

    Report Number
    3004486989-2012-00006
    Event Type
    Other
    Date Received
    May 15, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 14, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 3004486989-2012-00006. 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'S MOTHER AND DESCRIBED THE OCCURRENCE OF FOAMING AT MOUTH IN A PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT KID'S NASAL STRIPS) STRIP FOR NASAL CONGESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON (B)(6) 2012, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. APPROXIMATELY ONE DAY LATER, ON (B)(6) 2012, THE PATIENT EXPERIENCED FOAMING AT MOUTH. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN. VERBATIM TEXT: SHE USED BREATHE RIGHT KIDS ON HER CHILDREN AT NIGHT AND WHEN SHE SAW HER KID IN THE MORNING HER CHILD HAD FOAM IN HIS/HER MOUTH. FOLLOW-UP INFORMATION RECEIVED (B)(6) 2012, WHICH UPGRADED THE CASE TO SERIOUS. THE MOTHER USED BREATHE RIGHT KIDS ON HER CHILDREN AT NIGHT AND WHEN SHE SAW HER (B)(6) SON IN THE MIDDLE OF THE NIGHT HE HAD FOAM IN HIS MOUTH. HE WAS HALF UNCONSCIOUS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. WHEN THEY TRIED TO WAKE HIM UP HE WOKE UP AFTER COUPLE OF MINUTES AND RECOVERED. MEDICAL HELP WAS NOT SOUGHT. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. THE MOTHER CONSIDERED THAT IT WAS UNLIKELY THE EVENTS WERE RELATED TO USE OF BREATHE RIGHT NASAL STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT KID'S NASAL STRIPS NASAL STRIP LWF GLAXOSMITHKLINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other