BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS ADVANCED

    MDR report key: 3070209 · Received April 16, 2013

    Report

    Report Number
    2320643-2013-00003
    Event Type
    Other
    Date Received
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT ARE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (WIFE OF PATIENT) AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE DESQUAMATION IN (B)(6) MALE PATIENT WHO RECEIVED. BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS ADVANCED) 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. AT AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED APPLICATION SITE DESQUAMATION, APPLICATION SITE HEMORRHAGE AND APPLICATION SITE INFECTION. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BREATH RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE RESOLVED. THE CONSUMER DISCARDED THE BREATH RIGHT NASAL STRIP ADVANCED. THE PATIENT HAD USED BREATHE RIGHT TAN STRIPS. HE HAD USED THEM IN THE PAST WITH GOOD RESULTS. BREATHE RIGHT NASAL STRIPS ARE MANUFACTURED IN KNOXVILLE, TN IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR THE LOT NUMBER FOR THIS PRODUCT ARE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163096 BREATHE RIGHT NASAL STRIPS ADVANCED BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other