BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS CLEAR

    MDR report key: 2338407 · Received November 15, 2011

    Report

    Report Number
    3004486989-2011-00010
    Event Type
    Other
    Date Received
    November 15, 2011
    Report Date
    November 4, 2011
    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 MFG IN (B)(4). 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 PSORIASIS FACIAL IN A (B)(6) OLD MALE PT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR) FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED PSORIASIS. 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 PSORIASIS FACIAL, RASH AND ADHESIVE TAPE ALLERGY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. THE PT SAID THAT THE STRIPS HAD BEEN WORKING WELL. HE ATTRIBUTED THE EVENTS TO THE BREATHE RIGHT NASAL STRIPS. HE INQUIRED WHETHER THERE WERE STRIPS FOR MORE SENSITIVE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIPS CLEAR BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA 253201UJ10

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other