BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT MENTHOLATED NASAL STRIPS

    MDR report key: 2474226 · Received February 28, 2012

    Report

    Report Number
    3004486989-2012-00002
    Event Type
    Other
    Date Received
    February 28, 2012
    Report Date
    February 27, 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 MENTHOLATED NASAL STRIPS ARE MFG IN (B)(4), IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. THE EVENTS ASSOCIATED WITH BREATHE RIGHT ADVANCED NASAL STRIPS ARE NONSERIOUS AND A DEVICE REPORT WILL NOT BE SUBMITTED FOR THESE EVENTS. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ASTHMATIC ATTACK IN A (B)(6) FEMALE PT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT MENTHOLATED NASAL STRIPS) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED BREATHE RIGHT NASAL STRIPS ADVANCED. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS (TOPICAL). AT AN UNK TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED ASTHMATIC ATTACK. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BREATHE R MENTHOLATED NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS RESOLVED. WHEN THE PT USED BREATHE RIGHT NASAL STRIPS ADVANCED, SHE EXPERIENCED DEVICE MISUSE BY NOT MOISTENING THE BREATH RIGHT ADVANCED STRIP BEFORE REMOVING IT. WHEN SHE REMOVED THE STRIP, SHE EXPERIENCED SKIN RIPPED OFF AT APPLICATION SITE AND APPLICATION SITE SCAB. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other