BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS (ADVANCED & EXTRA)

    MDR report key: 1943562 · Received December 6, 2010

    Report

    Report Number
    3004486989-2010-00003
    Event Type
    Other
    Date Received
    December 6, 2010
    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). THE LOT NUMBER OF BREATHE RIGHT NASAL STRIPS ADVANCED IS KNOWN WHILE THE LOT NUMBER OF BREATHE RIGHT EXTRA NASAL STRIPS IS NOT KNOWN. IT IS UNK WHETHER THE PRODUCTS WILL BE SENT FOR QUALITY ASSURANCE TESTING. (B)(4). ADD'L LOT# UNK.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF EXACERBATION OF SLEEP APNEA IN A MALE 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 MILD SLEEP APNEA. CO-SUSPECT MEDICATION INCLUDED BREATHE RIGHT NASAL STRIPS EXTRA. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS (TOPICAL). AT AN UNK TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED EXACERBATION OF SLEEP APNEA DESCRIBED AS A COMPLETE APNEA WHERE HE STOPPED BREATHING. THE PT ALSO REPORTED THAT HE EXPERIENCED ON ONE OCCASION HE EXPERIENCED A MOMENTARY PARALYSIS, INABILITY TO MOVE FOR 4 TO 5 SECONDS. ON AN UNK DATE, THE PT STARTED THE BREATHE RIGHT EXTRA NASAL STRIPS. AT AN UNK TIME AFTER STARTING BREATHE RIGHT EXTRA NASAL STRIPS, THE PT EXPERIENCED EXACERBATION OF HIS SLEEP APNEA, BUT TO A LESSER DEGREE THAN WHEN USING THE ADVANCED VARIANT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY (B)(4). TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIPS (ADVANCED & EXTRA) NASAL STRIP LWF GLAXOSMITHKLINE 251603UUF10

    Patients

    Seq Age Sex Outcome Treatment
    1