BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS TAN

    MDR report key: 5976693 · Received September 26, 2016

    Report

    Report Number
    2320643-2016-00010
    Event Type
    Injury
    Date Received
    September 26, 2016
    Report Date
    September 9, 2016
    Manufacturer
    WEBTEC A DIVISION OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS TAN.

    Description of Event or Problem · 1

    CAN'T SLEEP WITHOUT THEM [DEPENDENCE]. PRODUCT AVAILABILITY ISSUE. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DEPENDENCE IN A (B)(6) FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR) NASAL STRIP FOR NASAL DISORDER AND SLEEP UNWELL. CO-SUSPECT PRODUCTS INCLUDED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP FOR NASAL DISORDER AND SLEEP UNWELL. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS CLEAR AND BREATHE RIGHT NASAL STRIPS TAN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS CLEAR AND BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED DEPENDENCE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT AVAILABILITY ISSUE. ON AN UNKNOWN DATE, THE OUTCOME OF THE DEPENDENCE AND PRODUCT AVAILABILITY ISSUE WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEPENDENCE AND PRODUCT AVAILABILITY ISSUE TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR AND BREATHE RIGHT NASAL STRIPS TAN. ADDITIONAL DETAILS: THE PATENT HAD BEEN USING BREATHE RIGHT STRIPS CLEAR VARIANT AND TAN VARIANT AND FOR 22 YEARS. SHE CAN'T SLEEP WITHOUT THEM. THERE'S ONLY ONE PHARMACY IN HER TOWN AND WAS INFORMED THAT THE PRODUCT WAS NO LONGER MADE. THE PATIENT WAS INFORMED THAT WHAT WERE GIVEN TO HER WERE THE LAST ONES AND I WAS TOLD THAT IT WILL BE THE LAST ONES OF BOTH VARIANTS. THE PATIENT PREFERS THE TAN VARIANT. THE PATIENT SAW A DOCTOR BEFORE SHE STARTED USING THEM. SHE WAS SENT TO A SPECIALIST TO CHECK IF THERE WAS A PROBLEM BUT THERE WAS NOT ANYTHING THAT HE COULD FIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629718 BREATHE RIGHT NASAL STRIPS TAN NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other