BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREATHE RIGHT NASAL STRIPS TAN

    MDR report key: 6807023 · Received August 21, 2017

    Report

    Report Number
    2320643-2017-00008
    Event Type
    Death
    Date Received
    August 21, 2017
    Report Date
    August 14, 2017
    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 (B)(4), BREATHE RIGHT NASAL STRIPS TAN.

    Description of Event or Problem · 1

    BEFORE MY HUSBAND DIED, HE USED THE BREATHE RIGHT NASAL STRIPS TAN LARGE [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS TAN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH TO BE RELATED TO BREATHE RIGHT NASAL STRIPS TAN. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 14 AUGUST 2017. THE REPORTER STATED, "BEFORE MY HUSBAND DIED, HE USED THE BREATHE RIGHT NASAL STRIPS TAN LARGE (COUNT NOT SPECIFIED)". LOT NUMBER AND EXPIRATION DATE WERE UNKNOWN. THIS IS 2 OF THE 2 REPORTS FROM THE SAME REPORTER. THIS CASE IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587914 BREATHE RIGHT NASAL STRIPS TAN NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O NO THERAPY (NO THERAPY)