BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINAZINA BREATHE RIGHT CLASSIC

    MDR report key: 11474999 · Received March 12, 2021

    Report

    Report Number
    2320643-2021-00001
    Event Type
    Injury
    Date Received
    March 12, 2021
    Report Date
    February 18, 2021
    Manufacturer
    WEBTEC DIV OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    CLASSIC PATCHES HAVE CAUSED BLEEDING [HEMORRHAGE]. SKIN IRRITATION [SKIN IRRITATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF HEMORRHAGE IN A FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (RINAZINA BREATHE RIGHT CLASSIC) NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED RINAZINA BREATHE RIGHT CLASSIC. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING RINAZINA BREATHE RIGHT CLASSIC, THE PATIENT EXPERIENCED HEMORRHAGE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SKIN IRRITATION. THE ACTION TAKEN WITH RINAZINA BREATHE RIGHT CLASSIC WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE HEMORRHAGE AND SKIN IRRITATION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE HEMORRHAGE AND SKIN IRRITATION TO BE RELATED TO RINAZINA BREATHE RIGHT CLASSIC. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL CENTER REPRESENTATIVE ON 18 FEB 2021. A CONSUMER CALLS TO ASK ABOUT THE AVAILABILITY OF THE CLEAR RINAZINA PATCHES AND ALSO ADDS THAT THE CLASSIC PATCHES HAVE CAUSED HER SKIN IRRITATION AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373235 RINAZINA BREATHE RIGHT CLASSIC NASAL STRIPS LWF WEBTEC DIV OF SCARPA HEALTHCARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other