BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS AVANCED

    MDR report key: 2549079 · Received April 18, 2012

    Report

    Report Number
    3004486989-2012-00005
    Event Type
    Other
    Date Received
    April 18, 2012
    Report Date
    April 17, 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

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 3004486989-2012-00005. BREATHE RIGHT NASAL STRIPS ARE MFG 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 AND DESCRIBED THE OCCURRENCE OF INTRAOCULAR PRESSURE INCREASED IN A (B)(6) FEMALE PT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS ADVANCED) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED GLAUCOMA. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS. AT AN UNK TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED INTRAOCULAR PRESSURE INCREASED (CONDITION AGGRAVATED), WORSENING OF CHRONIC GLAUCOMA AND EYE REDNESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. THE PT WAS TREATED WITH EYE MEDICATION (EYE DROPS). TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other