BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT EXTRA TAN

    MDR report key: 19213433 · Received April 30, 2024

    Report

    Report Number
    3010200299-2024-00001
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 30, 2024
    Manufacturer
    SCAPA TAPES NORTH AMERICA LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER'S WIFE REPORTED HUSBAND USED BREATHE RIGHT NASAL STRIPS FOR MANY YEARS. THE CONSUMER STATED THEY NO LONGER HAVE THE PRODUCT. NO INVESTIGATION CAN BE CONDUCTED WITHOUT HAVING PRODUCT INFORMATION. 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 08-APR-2024, A SPONTANEOUS REPORT THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING AN 80-YEAR-OLD MALE CONSUMER WHO USED BREATHE RIGHT EXTRA TAN STRIPS. THE REPORTER WAS THE CONSUMER'S WIFE. SHE REPORTED THAT FOR THE LAST 5 TO 7 YEARS, THAT HE WOULD WASH HIS NOSE IN THE EVENING AND APPLY A BREATHE RIGHT EXTRA TAN STRIP TO HIS NOSE AND KEEP IT ON OVERNIGHT AND IMMEDIATELY REMOVE IT IN THE MORNING. IT WAS NOT REPORTED IF HE FOLLOWED THE LABEL DIRECTIONS FOR REMOVING THE NASAL STRIP. ON UNSPECIFIED DATES, WHEN HE REMOVED THE BREATHE RIGHT EXTRA TAN STRIPS SKIN FROM HIS NOSE WAS REMOVED WHEN TAKING THE PRODUCT OFF. WHEN THIS HAPPENED, HE WOULD WAIT UNTIL THE AREA WAS HEALED BEFORE APPLYING A NEW STRIP IN THE EVENING. SHE WAS NOT SURE HOW MANY TIMES THIS HAS HAPPENED. HE NEVER SOUGHT MEDICAL CARE AND DID NOT HAVE FURTHER ISSUES. APPROXIMATELY A YEAR AGO IN 2023, HE DEVELOPED A RED SPOT ON HIS NOSE WHERE THE STRIP WOULD BE PLACED. HE WENT TO A DERMATOLOGIST. HE HAD A BIOPSY WITH CRYOTHERAPY. THE BIOPSY REVEALED BASAL CELL CARCINOMA. SUBSEQUENTLY, THE AREA OF THE NASAL SKIN WAS SURGICALLY REMOVED AT DIFFERENT STAGES SINCE HE WAS ON BLOOD THINNERS. AT THIS TIME, HE DISCONTINUED THE NASAL STRIPS. SHE MENTIONED SEVERAL TIMES THAT SHE WAS NOT SURE IF THE CANCER WAS RELATED BUT IT WAS WHERE THE STRIP WOULD SIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160053 BREATHE RIGHT EXTRA TAN NASAL STRIPS LWF SCAPA TAPES NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other MULTIVITAMIN| UNSPECIFIED ANTICOAGULANT| UNSPECIFIED DIABETIC MEDICATION| UNSPECIFIED HEART MEDICATION| VITAMIN D