BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS TAN

    MDR report key: 5586783 · Received April 19, 2016

    Report

    Report Number
    2320643-2016-00002
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 12, 2016
    Manufacturer
    WEBTEC A DIVISION OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MADE HIM BLEED [EPISTAXIS]. RIPPED SKIN OFF OF NOSE [SKIN PEELING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BLEEDING IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER 4484P8084760, EXPIRY DATE APRIL 2020) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED BLOOD PRESSURE HIGH, ALCOHOL USE (ONE BEER A DAY) AND CAFFEINE CONSUMER (2 CUPS OF TEA A DAY). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS TAN. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED BLEEDING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SKIN PEELING. ON AN UNKNOWN DATE, THE OUTCOME OF THE BLEEDING AND SKIN PEELING WERE UNKNOWN. THE REPORTER CONSIDERED THE BLEEDING AND SKIN PEELING TO BE RELATED TO BREATHE RIGHT NASAL STRIPS TAN. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, THE CONSUMER CALLED TO ADVISE THAT THE BREATHE RIGHT NASAL STRIPS TAN SMALL/MEDIUM STRIPS RIPPED THE SKIN OFF OF HIS NOSE AND MADE HIM BLEED. THE CONSUMER INDICATED THAT HIS NOSE WAS CLEAN AND DRY, THE LINING WAS REMOVED, THE STRIP WAS APPLIED TO THE CORRECT PART OF THE NOSE AND THE ENDS WERE PRESSED DOWN AND RUBBED GENTLY TO SECURE. THE CONSUMER WAS A FIRST TIME USER OF THE PRODUCT AND DID NOT SEE AN HEALTH CARE PROFESSIONAL FOLLOWING THE ONSET OF THE EVENTS. THE ACTION TAKEN FOR THE DEVICE BREATHE RIGHT NASAL STRIPS WAS UNKNOWN. THIS REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 19 APRIL 2016 AND IS AS FOLLOWS: THE EVENT CODING FOR THE EVENT MADE HIM BLEED (HEMORRHAGE) WAS CHANGED TO BLEEDING ON NOSE AND CASE WAS DOWNGRADED TO NON-SERIOUS. COMMENT: DOWNGRADE REPORT.

    Description of Event or Problem · 1

    MADE HIM BLEED [HEMORRHAGE]. RIPPED SKIN OFF OF NOSE [SKIN PEELING]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BLEEDING IN A (B)(6)-YEAR-OLD MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER 4484P8084760, EXPIRY DATE APRIL 2020) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED BLOOD PRESSURE HIGH, ALCOHOL USE (ONE BEER A DAY) AND CAFFEINE CONSUMER (2 CUPS OF TEA A DAY). CONCOMITANT PRODUCTS INCLUDED AMLODIPINE. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS TAN. ON (B)(6) 2016, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED BLEEDING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND SKIN PEELING. ON AN UNKNOWN DATE, THE OUTCOME OF THE BLEEDING AND SKIN PEELING WERE UNKNOWN. THE REPORTER CONSIDERED THE BLEEDING AND SKIN PEELING TO BE RELATED TO BREATHE RIGHT NASAL STRIPS TAN. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, THE CONSUMER CALLED TO ADVISE THAT THE BREATHE RIGHT NASAL STRIPS TAN SMALL/MEDIUM STRIPS RIPPED THE SKIN OFF OF HIS NOSE AND MADE HIM BLEED. THE CONSUMER INDICATED THAT HIS NOSE WAS CLEAN AND DRY, THE LINING WAS REMOVED, THE STRIP WAS APPLIED TO THE CORRECT PART OF THE NOSE AND THE ENDS WERE PRESSED DOWN AND RUBBED GENTLY TO SECURE. THE CONSUMER WAS A FIRST TIME USER OF THE PRODUCT AND DID NOT SEE AN HEALTH CARE PROFESSIONAL FOLLOWING THE ONSET OF THE EVENTS. THE ACTION TAKEN FOR THE DEVICE BREATHE RIGHT NASAL STRIPS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241583 BREATHE RIGHT NASAL STRIPS TAN NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE 4484P8084760

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other