BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT

    MDR report key: 158080 · Received March 20, 1998

    Report

    Report Number
    MW1013289
    Event Type
    Other
    Date Received
    March 20, 1998
    Date of Event
    March 16, 1998
    Report Date
    March 20, 1998
    Manufacturer
    CNS, INC.
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR, SHE HAS BEEN USING THE PRODUCT APPROX ONE MO. THE ONLY DIFFICULTY ENCOUNTERED PREVIOUSLY WITH THE PRODUCT HAS BEEN A FAILURE TO STICK. ON THE ABOVE DATE, THE RPTR WHILE REMOVING THE BREATHE RIGHT STRIP ALSO PEELED THE SKIN FROM THE BRIDGE OF HER NOSE. THE RPTR STATED AN OBVIOUS OPEN WOUND WAS LEFT. SHE HAS SOUGHT NO MEDICAL ATTENTION, BUT HAS TREATED THE WOUND WITH HOME REMEDIES. SHE STATES THE WOUND IS HEALING, BUT SHE IS CONCERNED ABOUT SCARRING. ACCORDING TO THE RPTR, SHE HAS FOLLOWED ALL THE MFR'S INSTRUCTIONS FOR APPLYING AND REMOVING THE PRODUCT. SHE HAS HAD NO PREVIOUS SKIN IRRITATION AT THE SITE. THE RPTR STATES NO WARNINGS ARE GIVEN ABOUT AN INCIDENT OF THIS TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT * LWF CNS, INC. NI 0152762

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other