BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS

    MDR report key: 7183783 · Received January 11, 2018

    Report

    Report Number
    2320643-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Report Date
    January 1, 2018
    Manufacturer
    WEBTEC A DIVISION OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    2320643-2018-00001 IS ASSOCIATED WITH (B)(4), BREATHE RIGHT NASAL STRIPS.

    Description of Event or Problem · 0

    THE REGULAR ONES DIDN'T STICK AS WELL AND ITCH. [APPLICATION SITE ITCHING] BLEEDING DUE TO BREATHE RIGHT EXTRA. [APPLICATION SITE HEMORRHAGE] SOME SKIN WAS PULLED FROM MY NOSE. [APPLICATION SITE PEELING] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF HEMORRHAGE IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2017, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), APPLICATION SITE ITCHING AND PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEMORRHAGE, APPLICATION SITE ITCHING AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE HEMORRHAGE AND APPLICATION SITE ITCHING TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 01 JANUARY 2018. CONSUMER REPORTED BLEEDING DUE TO BREATHE RIGHT NASAL STRIP. FOLLOW UP INFORMATION WAS RECEIVED ON 02 JANUARY 2018. CONSUMER SAID, "THE REGULAR ONES DIDN'T STICK AS WELL AND ITCH. I FOUND THE EXTRA STAY ON BETTER AND DIDN'T ITCH." ACTION TAKEN FOR THIS WAS UNKNOWN. INITIAL AND FOLLOW UP INFORMATION WAS ADDED IN ABOVE NARRATIVE. FOLLOW UP INFORMATION WAS RECEIVED ON 31 JANUARY 2018 VIA RETURNED CONSUMER AUTHORIZATION FORM. THE PATIENT SAID, " DID NOT NEED A DOCTOR, SOME SKIN WAS PULLED FROM MY NOSE, CONSUMER STOP USING PRODUCT." ACTION TAKEN WITHDRAWN AND DECHALLENGE UNKNOWN. COMMENT: *DOWNGRADE REPORT*

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BLEEDING DUE TO BREATHE RIGHT EXTRA. [HEMORRHAGE] THE REGULAR ONES DIDN'T STICK AS WELL AND ITCH. [APPLICATION SITE ITCHING] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF HEMORRHAGE IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2017, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), APPLICATION SITE ITCHING AND PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEMORRHAGE, APPLICATION SITE ITCHING AND PRODUCT COMPLAINT WERE UNKNOWN. THE REPORTER CONSIDERED THE HEMORRHAGE AND APPLICATION SITE ITCHING TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 01 JANUARY 2018. CONSUMER REPORTED BLEEDING DUE TO BREATHE RIGHT NASAL STRIP. FOLLOW UP INFORMATION WAS RECEIVED ON 02 JANUARY 2018. CONSUMER SAID, "THE REGULAR ONES DIDN'T STICK AS WELL AND ITCH. I FOUND THE EXTRA STAY ON BETTER AND DIDN'T ITCH." ACTION TAKEN FOR THIS WAS UNKNOWN. INITIAL AND FOLLOW UP INFORMATION WAS ADDED IN ABOVE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28469 BREATHE RIGHT NASAL STRIPS NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NO THERAPY (NO THERAPY)