BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 6210518 · Received December 28, 2016

    Report

    Report Number
    2320643-2016-00014
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    December 19, 2016
    Manufacturer
    WEBTEC A DIVISION OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDICTED TO BREATHE RIGHT NASAL STRIPS. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ADDICTION IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED ADDICTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT ). BREATHE RIGHT NASAL STRIPS WAS CONTINUED WITH NO CHANGE. ON AN UNKNOWN DATE, THE OUTCOME OF THE ADDICTION WAS UNKNOWN. THE REPORTER CONSIDERED THE ADDICTION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 19 DECEMBER 2016. CONSUMER INDICATED THAT HE WAS ADDICTED TO BREATHE RIGHT NASAL STRIPS (VARIANT NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858133 BREATHE RIGHT NASAL STRIPS NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other