BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 319178 · Received March 6, 2001

    Report

    Report Number
    2183550-1996-00001
    Event Type
    Injury
    Date Received
    March 6, 2001
    Date of Event
    January 1, 1996
    Report Date
    January 27, 1996
    Manufacturer
    CNS, INC.
    Product Code
    LWF
    Removal / Correction Number
    BR149
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAD USED NASAL STRIPS SUCCESSFULLY FOR SEVERAL DAYS TO REDUCE/ELIMINATE SNORING. AWOKE ONE MORNING WITH NOSEBLEED. APPLIED PRESSURE AND STOPPED SUCCESSFULLY. STARTED BLEEDING AGAIN PROFUSELY AT 8PM. CALLED AMBULANCE, WENT TO ER FOR CAUTERIZATION. SAW ENT PHYSICIAN 2 WEEKS LATER. SUBSEQUENTLY UNDERWENT SURGERY FOR NASAL SEPTUM RECONSTRUCTION, POLYPECTOMY AND SINUS SCRAPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9440 BREATHE RIGHT NASAL STRIPS EXTERNAL NASAL DILATOR LWF CNS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention AND VARIOUS (UNSPECIFIED) THERAPIES - NOT| CONSIDERED RELEVANT.| PT REPORTED PREVIOUS NOSEBLEEDS, CHRONIC SINUSITIS