BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 2445525 · Received February 3, 2012

    Report

    Report Number
    3004486989-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Report Date
    February 2, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY STAFF FROM A "DRUG STORE" AND DESCRIBED THE OCCURRENCE OF LOSS OF SMELL IN A FEMALE PT OF ABOUT (B)(6) YEARS WHO RECEIVED BREATHE RIGHT NASAL STRIPS FOR NASAL CONGESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. IN THE MIDDLE OF (B)(6) 2011 THE PT STARTED BREATHE RIGHT NASAL STRIPS (USED EXTERNALLY). IT WAS REPORTED THAT "THE PT HAD USED THE NASAL STRIP FOR ABOUT 2 TO 3 TIMES, AND EACH TIME SHE USED IT FOR MORE THAN 12 HOURS". AT AN UNK TIME WHEN TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED, THE PT EXPERIENCED LOSS OF SMELL. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. BREATHE THE RIGHT NASAL STRIPS ARE MANUFACTURED IN (B)(4), AND NEITHER THE LOT NUMBER NOR THE PRODUCT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other