BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS EXTRA

    MDR report key: 3593241 · Received January 15, 2014

    Report

    Report Number
    2320643-2014-00001
    Event Type
    Other
    Date Received
    January 15, 2014
    Report Date
    January 10, 2014
    Manufacturer
    GLAXOSMITHKLINE
    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 APPLICATION SITE INFECTION IN A (B)(6)-YEAR-OLD FEMALE PT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS EXTRA) STRIP FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS (TOPICAL). AT AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PT EXPERIENCED APPLICATION SITE INFECTION, APPLICATION SITE SKIN TEAR, HOLES IN SKIN AT APPLICATION SITE, SORENESS AT APPLICATION SITE, APPLICATION SITE REDNESS AND DEVICE MISUSE. THE PT REPORTED THAT SHE DID NOT USE WATER TO REMOVE BREATHE RIGHT EXTRA NASAL STRIPS (DEVICE MISUSE). 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. BREATHE RIGHT NASAL STRIPS EXTRA IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS 3610XX692500. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41054 BREATHE RIGHT NASAL STRIPS EXTRA BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA 3610XX692500

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other UNSPECIFIED MEDICATIONS (UNK - UNK)