BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATH RIGHT ORIGINAL

    MDR report key: 8623394 · Received May 20, 2019

    Report

    Report Number
    2320643-2019-00004
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    April 28, 2019
    Report Date
    May 1, 2019
    Manufacturer
    WEBTEC DIV OF SCARPA HEALTHCARE
    Product Code
    LWF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT QUALITY INVESTIGATION 20 SEPTEMBER 2019: PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. THIS PRODUCT IS MANUFACTURED UNDER CONTROLLED CONDITIONS, SUBJECT TO ROUTINE QUALITY CHECKS. ALL PRODUCTS UNDERGO ROUTINE RELEASE TESTING AND MUST MEET ALL SPECIFICATIONS BEFORE BEING SHIPPED. ARGUS CASE (B)(4).

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SWELLING IN A 52-YEAR-OLD FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATH RIGHT ORIGINAL) NASAL STRIP (BATCH NUMBER 1801935, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED BLOOD CHOLESTEROL INCREASED. CONCOMITANT PRODUCTS INCLUDED ROSUVASTATIN CALCIUM (CRESTOR). ON (B)(6) 2019, THE PATIENT STARTED BREATH RIGHT ORIGINAL. ON (B)(6) 2019, 4 DAYS AFTER STARTING BREATH RIGHT ORIGINAL, THE PATIENT EXPERIENCED SWELLING (SERIOUS CRITERIA HOSPITALIZATION). ON (B)(6) 2019, THE PATIENT EXPERIENCED SWOLLEN LIPS AND NASAL INFLAMMATION. ON (B)(6) 2019, THE PATIENT EXPERIENCED PERIPHERAL SWELLING. ON (B)(6) 2019, THE PATIENT EXPERIENCED CELLULITE AND SWELLING OF FACE. BREATH RIGHT ORIGINAL WAS DISCONTINUED ON (B)(6) 2019 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE SWELLING, CELLULITE, SWELLING OF FACE, PERIPHERAL SWELLING, SWOLLEN LIPS AND NASAL INFLAMMATION WERE RECOVERING/RESOLVING. THE REPORTER CONSIDERED THE SWELLING, CELLULITE AND SWELLING OF FACE TO BE RELATED TO BREATH RIGHT ORIGINAL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PERIPHERAL SWELLING, SWOLLEN LIPS AND NASAL INFLAMMATION TO BE RELATED TO BREATH RIGHT ORIGINAL. THIS REPORT WAS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE INITIAL AND FOLLOW UP WAS PROCESSED TOGETHER. THE CONSUMER REPORTED THAT SHE STARTED USING BREATHRIGHT. SHE USED IT EVERY NIGHT. SHE STARTED FEELING SWOLLEN AND ON (B)(6) 2019 SHE WOKE UP AND WAS SLIGHTLY SW[?]LLEN ALL OVER HER BODY AND BECAME MORE SWOLLEN IN NOSE AND LIPS AND WAS SWOLLEN IN LEGS, ARMS, LIPS AND FACE. ON (B)(6) 2019 SHE VISITED AN EAR NOSE THROAT PHYSICIAN WHO GAVE HER A CREAM FOR THE NOSE AND ANTI HISTAMINE DRUG (NOT SPECIFIED), BUT THE SWELLING WAS NOT RESOLVED, SO ON SHE VISITED THE HOSPITAL. FOLLOW UP INFORMATION WAS RECEIVED FROM CONSUMER ON 03 MAY 2019: THE CONSUMER REPORTED THAT SHE WAS HOSPITALIZED AND SHE WAS DIAGNOSED WITH CELLULITE AND INFLAMMATION IN FACE. THE SYMPTOMS STARTED RECOVERING. SHE WAS ON THERAPY WITH CRESTOR FOR MANY YEARS. SHE DID NOT STARTED ANY NEW DRUG AND DID NOT EAT ANY DIFFERENT FOOD THE DAYS SHE USED BREATHRIGHT. FOLLOW UP INFORMATION WAS RECEIVED ON 20 SEP 2019 FROM QA DEPARTMENT: QUALITY ASSURANCE ANALYSIS REVEALED THE COMPLAINT NOW CONSIDER TO BE CLOSED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE PRODUCT COMPLAINT WAS UNKNOWN. NO ADVERSE EVENT ASSOCIATED, PRODUCT QUALITY COMPLAINT ONLY.

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID (B)(4).

    Description of Event or Problem · 1

    SWELLING/SLIGHTLY SWOLLEN ALL OVER HER BODY/FEELING SWOLLEN [SWELLING], CELLULITE IN FACE [CELLULITE], INFLAMMATION IN FACE/SWOLLEN FACE [FACIAL SWELLING], SWOLLEN IN LEGS, ARMS [PERIPHERAL SWELLING], SWOLLEN LIPS [LIP SWELLING], SWOLLEN NOSE [NASAL INFLAMMATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF SWELLING IN A (B)(6) FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATH RIGHT ORIGINAL) NASAL STRIP (BATCH NUMBER 1801935, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED BLOOD CHOLESTEROL INCREASED. CONCOMITANT PRODUCTS INCLUDED ROSUVASTATIN CALCIUM (CRESTOR). ON (B)(6) 2019, THE PATIENT STARTED BREATH RIGHT ORIGINAL. ON (B)(6) 2019, 4 DAYS AFTER STARTING BREATH RIGHT ORIGINAL, THE PATIENT EXPERIENCED SWELLING (SERIOUS CRITERIA HOSPITALIZATION). ON (B)(6) 2019, THE PATIENT EXPERIENCED SWOLLEN LIPS AND NASAL INFLAMMATION. ON (B)(6) 2019, THE PATIENT EXPERIENCED PERIPHERAL SWELLING. ON (B)(6) 2019, THE PATIENT EXPERIENCED CELLULITE AND SWELLING OF FACE. BREATH RIGHT ORIGINAL WAS DISCONTINUED ON (B)(6) 2019 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE SWELLING, CELLULITE, SWELLING OF FACE, PERIPHERAL SWELLING, SWOLLEN LIPS AND NASAL INFLAMMATION WERE RECOVERING/RESOLVING. THE REPORTER CONSIDERED THE SWELLING, CELLULITE AND SWELLING OF FACE TO BE RELATED TO BREATH RIGHT ORIGINAL. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE PERIPHERAL SWELLING, SWOLLEN LIPS AND NASAL INFLAMMATION TO BE RELATED TO BREATH RIGHT ORIGINAL. ADDITIONAL DETAILS: THE INITIAL AND FOLLOW UP WAS PROCESSED TOGETHER. THE CONSUMER REPORTED THAT SHE STARTED USING BREATHRIGHT. SHE USED IT EVERY NIGHT. SHE STARTED FEELING SWOLLEN AND ON (B)(6) 2019 SHE WOKE UP AND WAS SLIGHTLY SWOLLEN ALL OVER HER BODY AND BECAME MORE SWOLLEN IN NOSE AND LIPS AND WAS SWOLLEN IN LEGS, ARMS, LIPS AND FACE. ON (B)(6) 2019 SHE VISITED AN EAR NOSE THROAT PHYSICIAN WHO GAVE HER A CREAM FOR THE NOSE AND ANTI HISTAMINE DRUG (NOT SPECIFIED), BUT THE SWELLING WAS NOT RESOLVED, SO ON SHE VISITED THE HOSPITAL. FOLLOW UP INFORMATION WAS RECEIVED FROM CONSUMER ON 03 MAY 2019: THE CONSUMER REPORTED THAT SHE WAS HOSPITALIZED AND SHE WAS DIAGNOSED WITH CELLULITE AND INFLAMMATION IN FACE. THE SYMPTOMS STARTED RECOVERING. SHE WAS ON THERAPY WITH CRESTOR FOR MANY YEARS. SHE DID NOT STARTED ANY NEW DRUG AND DID NOT EAT ANY DIFFERENT FOOD THE DAYS SHE USED BREATHRIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417298 BREATH RIGHT ORIGINAL NASAL STRIPS LWF WEBTEC DIV OF SCARPA HEALTHCARE 1801935

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization CRESTOR (ROSUVASTATIN CALCIUM) UNKNOWN ONGOING| CRESTOR (ROSUVASTATIN CALCIUM) UNKNOWN ONGOING