BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIP (VARIANT UNKNOWN)

    MDR report key: 2061037 · Received March 31, 2011

    Report

    Report Number
    3004486989-2011-00005
    Event Type
    Other
    Date Received
    March 31, 2011
    Report Date
    March 31, 2011
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BASAL CELL CARCINOMA IN A MALE PT WHO REC'D BREATHE RIGHT NASAL STRIPS FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS. AT AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED BASAL CELL CARCINOMA. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNK. CONSUMER REPORTED USING AN UNK VARIANT OF BREATHE RIGHT FOR APPROX 2 YEARS PRIOR TO REPORTING. CONSUMER REPORTED HE WAS RECENTLY DIAGNOSED WITH BASAL CELL NASAL CANCER. THE PT WOULD NOT PROVIDE CONTACT INFORMATION; THEREFORE, THIS CASE IS LOST TO F/U. BREATHE RIGHT NASAL STRIPS ARE MANUFACTURED IN (B)(4) IN THE UNITED STATES, AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT ARE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIP (VARIANT UNKNOWN) NASAL STRIP LWF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other