BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT CLEAR NASA STRIPS SMALL/MEDIUM

    MDR report key: 20127400 · Received September 3, 2024

    Report

    Report Number
    3010200299-2024-00002
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 5, 2024
    Report Date
    October 9, 2024
    Manufacturer
    SCAPA TAPES NORTH AMERICA LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION CONCLUDED NO ISSUES WERE OBSERVED DURING MANUFACTURING AND ALL TESTING REQUIREMENTS MET THE SPECIFICATIONS FOR THIS LOT. THIS REPORT IS MADE BY FCH WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Additional Manufacturer Narrative · 0

    THE CONSUMER RETURNED THE COMPLAINT SAMPLE. THE COMPLAINT SAMPLE WAS EVALUATED, AND THE INVESTIGATION CONCLUDED NO ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. IN ADDITION, THE INVESTIGATION CONCLUDED THAT NO ISSUES WERE OBSERVED DURING MANUFACTURING OF THIS DEVICE LOT AND ALL TESTING REQUIREMENTS MET SPECIFICATIONS. THIS REPORT IS MADE BY FCH WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Description of Event or Problem · 0

    ON 09-AUG-2024, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE FROM A 61-YEAR-OLD FEMALE CONSUMER, WHO IS A PHYSICIAN WHO USED BREATHE RIGHT CLEAR SMALL/MEDIUM NASAL STRIPS. A LONG TIME AGO THE CONSUMER STARTED USING BREATH RIGHT CLEAR SMALL/MEDIUM NASAL STRIPS FOR AN UNKNOWN INDICATION. ON AN UNSPECIFIED DATE IN JUL-2024, THE CONSUMER EXPERIENCED A RASH ON THE BRIDGE OF HER NOSE. ON (B)(6) 2024, SHE STARTED EXPERIENCING SWELLING, DIFFICULTY BREATHING, A FACIAL RASH, HIVES ALL OVER, DIFFICULTY SWALLOWING, DIARRHEA, AND WHEEZING. THE SAME DAY SHE WENT TO AN EMERGENCY ROOM (ER) AND WAS TREATED WITH EPINEPHRINE, STEROIDS, AND INTRAVENOUS SOLUMEDROL (METHYLPREDNISOLONE). BLOOD WORK AND FOOD ALLERGY TESTING WERE COMPLETED WHICH CAME BACK NORMAL. SHE WAS ADMITTED AND STAYED FOR 2 DAYS WITH A DIAGNOSIS OF AN ANAPHYLACTIC REACTION. SHE LAST USED THE PRODUCT ON THE NIGHT OF (B)(6) THROUGH THE MORNING OF (B)(6) 2024. SHE WENT TO THE ER AGAIN ON (B)(6) 2024 DUE TO EXPERIENCING THE SAME SYMPTOMS AS SHE HAD ON (B)(6) 2024. SHE HAD BLOOD WORK COMPLETED WITH NORMAL RESULTS. SHE WAS GIVEN EPINEPHRINE AND STEROIDS AND WAS RELEASED WITH STEROIDS. AS OF (B)(6) 2024, HER SYMPTOMS WERE ONGOING BUT NOT AS SEVERE AS WHEN SHE WAS IN THE ER. THE REPORTER WAS A DOCTOR WHO NOTED SHE HAD TO WEAR A N95 MASK AT WORK AND SHE ANTICIPATED LOOKING AT THE INGREDIENTS OF THE MASK. THE CONSUMER HAS AN APPOINTMENT WITH AN ALLERGIST IN (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712060 BREATHE RIGHT CLEAR NASA STRIPS SMALL/MEDIUM NASAL STRIPS LWF SCAPA TAPES NORTH AMERICA LLC G1812069

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Life Threatening| O| H FAMOTIDINE.| MONTELUKAST.| UNSPECIFIED STEROIDS.| ZYRTEC (CETIRIZINE HYDROCHLORIDE).