BEUDAMED
    FDA Adverse Event Summary report: N

    BREATHE RIGHT

    MDR report key: 16923 · Received October 18, 1994

    Report

    Report Number
    MW1003720
    Date Received
    October 18, 1994
    Date of Event
    October 12, 1994
    Report Date
    October 17, 1994
    Manufacturer
    CNS, INC.
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UPON AWAKENING AFTER USING THE PRODUCT FOR FOUR CONSECUTIVE NIGHTS, A PT EXPERIENCED SEVERE PAIN IN HER EYES. SHE WENT TO AN OPHTHALMOLOGIST WHO TOLD HER THAT THE FILM OVER HER CORNEA HAD ERODED POSSIBLY BECAUSE THE PRODUCT CAUSED HER EYES TO DRY OUT. THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT LWF CNS, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 *