BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 715262 · Received May 12, 2006

    Report

    Report Number
    2183550-2006-00001
    Event Type
    Malfunction
    Date Received
    May 12, 2006
    Date of Event
    April 5, 2006
    Report Date
    May 11, 2006
    Manufacturer
    CNS, INC.
    Product Code
    LWF
    PMA / PMN Number
    K921220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REMOVED A BREATHE RIGHT NASAL STRIP FROM ITS SECONDARY PACKAGE (BOX). (THE PACKAGE HAD PREVIOUSLY BEEN OPENED AND TWO NASAL STRIPS HAD BEEN REMOVED.) EACH STRIP IS INDIVIDUALLY PACKAGED IN COLD SEAL (PRIMARY PACKAGE). THE CONSUMER NOTICED A RUSTED UTILITY KNIFE BLADE INSIDE OF THE PACKAGE. THE CONSUMER REMOVED THE BLADE FROM THE PACKAGE. THE CONSUMER WAS NOT CUT OR INJURED BY THE BLADE AND DID NOT SEEK MEDICAL ATTENTION. THE CONSUMER'S MOTHER RETURNED THE PACKAGE AND BLADE TO THE PHARMACY FROM WHICH IT WAS PURCHASED. ON THE EVENING OF 4/5/2006, THE PHARMACIST CALLED THE CNS CONSUMER RESPONSE CENTER TO NOTIFY CNS OF THE PACKAGE AND THE BLADE. ON ONE DAY LATER, CNS CONTACTED THE PHARMACIST AND MADE ARRANGEMENTS TO HAVE THE PACKAGE AND BLADE SENT TO CNS. THE PACKAGE/BLADE WERE RECIEVED AT CNS ON TWO DAYS AFTER EVENT DATE. THE CONSUMER WAS NOT INJURED, SO IT WAS DETERMINED THAT AN MDR WAS NOT REQUIRED. IN 4/06, THE CONSUMER'S MOTHER REPORTED THAT THE CONSUMER WAS SUFFERRING FROM STRESS RELATED TO THIS INCIDENT. ACCORDING TO THE CONSUMER'S MOTHER, THE CONSUMER'S SYMPTOMS OF CROHN'S DISEASE AND AGORAPHOBIA WAS AGGRAVATED DUE TO THE STRESS OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREATHE RIGHT NASAL STRIPS LWF LWF CNS, INC. SM/MED, CLEAR *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other