BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS EXTRA

    MDR report key: 4121390 · Received September 24, 2014

    Report

    Report Number
    2320643-2014-00007
    Event Type
    Other
    Date Received
    September 24, 2014
    Report Date
    September 23, 2014
    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 NASAL STRIPS ARE MANUFACTURED IN (B)(4) IN THE UNITED STATES. THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF BASAL CELL CARCINOMA IN A (B)(6) FEMALE PATIENT 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. CO-SUSPECT MEDICATION INCLUDED BREATHE RIGHT NASAL STRIPS EXTRA. ON AN UNK DATE IN 2000, THE PATIENT STARTED THE ADVANCED AND EXTRA VARIANTS OF BREATHE RIGHT NASAL STRIPS. AT AN UNK TIME AFTER STARTING THE VARIANTS OF BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED BASAL CELL CARCINOMA AND APPLICATION SITE HEMORRHAGE. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH THE VARIANTS OF BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER HAS BEEN USING BREATHE RIGHT ADVANCED AND BREATHE RIGHT EXTRA SINCE THE YEAR 2000. SHE DISCONTINUED USING BREATHE RIGHT ADVANCED AND BREATHE RIGHT EXTRA ABOUT A YEAR AGO BECAUSE THE AREA ON HER LEFT NOSTRIL BEGAN TO BLEED, SO SHE WENT FOR A BIOPSY. SHE HAS BEEN DIAGNOSED WITH AE-BASAL CELL CARCINOMA ON HER LEFT NOSTRIL. MULTIPLE LOST CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595468 BREATHE RIGHT NASAL STRIPS EXTRA BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA 263602XXK10

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other