BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT EXTRA CLEAR NASAL STRIP

    MDR report key: 14017007 · Received April 5, 2022

    Report

    Report Number
    3010200299-2022-00001
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    January 1, 2021
    Report Date
    April 4, 2022
    Manufacturer
    SCAPA TAPES NORTH AMERICA, LLC
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. TEST RESULTS CONFIRM RETAIN SAMPLES FROM THE SAME LOT MET SPECIFICATIONS AND NO ISSUES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT.

    Description of Event or Problem · 0

    THIS MDR WAS ORIGINALLY RECEIVED ON 07-JAN-2022 HOWEVER THE CASE WAS NOT ASSESSED AS SERIOUS AND REPORTABLE AS A 30-DAY MDR UNTIL ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP ON 07-MARCH-2022. ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED FROM A CONSUMER VIA TELEPHONE REGARDING AN (B)(6) MALE WHO USED BREATHE RIGHT EXTRA CLEAR NASAL STRIPS. ON 07-MAR-2022, ADDITIONAL INFORMATION WAS RECEIVED, AND THE REPORT WAS ASSESSED TO BE A REPORTABLE MEDICAL DEVICE COMPLAINT. MEDICAL HISTORY INCLUDED DIABETES, HIGH BLOOD PRESSURE, AND HIGH CHOLESTEROL. ALLERGIES INCLUDED PENICILLIN AND LATEX. CONCOMITANT PRODUCTS INCLUDED METFORMIN, AN UNSPECIFIED CHOLESTEROL MEDICATION, AND AN UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION. ON AN UNSPECIFIED DATE, REPORTED AS FOR "YEARS", THE CONSUMER STARTED USING BREATHE RIGHT EXTRA CLEAR NASAL STRIPS APPLIED TOPICALLY FOR AN UNSPECIFIED INDICATION. ON AN UNSPECIFIED DATE, AFTER USING THE PRODUCT AND "MAYBE 3-6 MONTHS AGO" (RELATIVE TO (B)(6) 2022; FURTHER CLARIFIED IT WAS SOME TIME AFTER USING THE PRODUCT), HE STARTED HAVING ISSUES FOCUSING HIS VISION. HE HAD BEEN TO AN EYE DOCTOR AT LEAST THREE TIMES AND THEY COULD NOT FIND ANYTHING WRONG OTHER THAN DRY EYES. SUBSEQUENTLY, DRY EYE DROPS WERE RECOMMENDED. THE CONSUMER NOTED THE PACKAGING STATED IT CONTAINED LATEX, BUT NO LATEX WAS IN THE ACTUAL PRODUCT. ON (B)(6) 2022, IT WAS LEARNED THAT THE CONSUMER STILL HAD SOME FOCUSING ISSUES AND DRY EYES. HE CLARIFIED THAT WHEN HE FIRST VISITED HIS DOCTOR, HE WAS GIVEN A NEW STRONGER PRESCRIPTION FOR GLASSES. HE RETURNED TO HIS DOCTOR A COUPLE OF TIMES DUE TO HIS FOCUSING ISSUES AND DRY EYES AND WAS TOLD THERE WAS NOTHING WRONG. AS OF (B)(6) 2022, HE CONTINUED TO USE THE EYE DROPS AND HE FELT THE SAME. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS MADE BY FCB WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912901 BREATHE RIGHT EXTRA CLEAR NASAL STRIP NASAL STRIPS LWF SCAPA TAPES NORTH AMERICA, LLC CONFIDENTIAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention CHOLESTEROL MEDICATION (UNSPECIFIED)| HIGH BLOOD PRESSURE MEDICATION (UNSPECIFIED)| METFORMIN