BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHE RIGHT NASAL STRIPS TAN

    MDR report key: 6601939 · Received May 31, 2017

    Report

    Report Number
    2320643-2017-00005
    Event Type
    Injury
    Date Received
    May 31, 2017
    Report Date
    May 1, 2017
    Manufacturer
    WEBTEC A DIVISION OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS TAN.

    Description of Event or Problem · 1

    SKIN BECOMES DIFFERENT/N BLOOD UNDERNEATH SKIN/ MARKS [HEMORRHAGE SUBCUTANEOUS]. NOSE BECOMES BIGGER [NASAL DISORDER]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SKIN DISORDER IN A (B)(6) MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER 491408645570, EXPIRY DATE UNKNOWN) FOR NASAL CONGESTION. CONCOMITANT PRODUCTS INCLUDED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR). ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS TAN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED SKIN DISORDER AND NASAL DISORDER. ON AN UNKNOWN DATE, THE OUTCOME OF THE SKIN DISORDER AND NASAL DISORDER WERE NOT RECOVERED/NOT RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SKIN DISORDER AND NASAL DISORDER TO BE RELATED TO BREATHE RIGHT NASAL STRIPS TAN. ADDITIONAL DETAILS, CONSUMER WAS USING THE PRODUCT FOR 1 WEEK NOW AT MY NOSE. HE NOTICED MY SKIN BECOMES DIFFERENT. MY NOSE BECOMES BIGGER. AND HE FOUND OUT THERE'S BLOOD UNDERNEATH MY SKIN. BEFORE, HE USED THE PLASTIC ONE (CLEAR) (BREATHE RIGHT NASAL STRIPS CLEAR), IT WAS GOOD. THE ACTION TAKEN OD BREATHE RIGHT NASAL STRIPS CLEAR WAS UNKNOWN. FOLLOW UP RECEIVED ON 08 MAY 2017. ON AN UNKNOWN DATE, THE OUTCOME OF THE SKIN DISORDER AND NASAL DISORDER WERE RECOVERING/RESOLVING. HIS NOSE WAS STARTING TO RECOVER. HE WENT DOCTOR AND SHE TOLD THAT HE WAS ALLERGIC TO THE TAN STRIPS. HE GOT THE CLEAR ONE NOW, HE HAD IT REPLACED AT (B)(6) PHARMACY. THERE'S NO MORE BLOOD, NO MORE MARKS. SHE GAVE SOME KIND OF CREAM TO RUB ON NOSE. FOLLOW UP WAS RECEIVED ON 22 MAY 2017, THIS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBED THE OCCURRENCE OF SUBCUTANEOUS BLEEDING IN A (B)(6) MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER 491408645570, EXPIRY DATE UNKNOWN) FOR NASAL CONGESTION. CONCURRENT MEDICAL CONDITIONS INCLUDED DRUG ALLERGY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED SUBCUTANEOUS BLEEDING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND NASAL DISORDER. ON AN UNKNOWN DATE, THE OUTCOME OF THE SUBCUTANEOUS BLEEDING AND NASAL DISORDER WERE RECOVERING/RESOLVING. THE REPORTER CONSIDERED THE SUBCUTANEOUS BLEEDING AND NASAL DISORDER TO BE ALMOST CERTAINLY RELATED TO BREATHE RIGHT NASAL STRIPS TAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383524 BREATHE RIGHT NASAL STRIPS TAN NASAL STRIPS LWF WEBTEC A DIVISION OF SCARPA HEALTHCARE 491408645570

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other BREATHE RIGHT NASAL STRIPS CLEAR