BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREATHE RIGHT NASAL STRIPS ADVANCED

    MDR report key: 3935928 · Received June 18, 2014

    Report

    Report Number
    2320643-2014-00004
    Event Type
    Other
    Date Received
    June 18, 2014
    Date of Event
    February 21, 2014
    Report Date
    June 16, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    LWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AE FOLLOW UP RECEIVED ON (B)(6) 2014 - CONSUMER REPORTED THAT SINCE LAST FRIDAY, THE SKIN IS RAISED AT THE APPLICATION SITE 2 MILLIMETERS FROM USING BREATHE RIGHT ADVANCED NASAL STRIP. CONSUMER REPORTED THE NEW EXPERIENCES OF BRIGHT RED AT APPLICATION SITE, PURPLE NOSE FURTHER DESCRIBED AS HER NOSE IS PURPLE AT APPLICATION SITE AND SHE HAS A PERFECT OUTLINE ON HER NOSE FROM THE 4 POINTS FROM BREATHE RIGHT ADVANCED NASAL STRIP. CONSUMER REPORTED THAT SHE WAS GIVEN A STEROID TO USE AND IT'S NOT HELPING AT ALL. NOTHING HAS CHANGED AND ALL EXPERIENCES ARE ONGOING. AE FOLLOW-UP INFO WAS RECEIVED VIA MAIL ON 06 JUNE 2014. THE DENTIST (WHO IS THE PT) WROTE THAT BREATHE RIGHT NASAL STRIPS ADVANCED FOR SENSITIVE SKIN HAS CAUSED A PAINFUL AND PERMANENT SKIN INFECTION. SHE REPORTED THAT IN THE MIDDLE OF THE THIRD NIGHT OF USE OF THE PRODUCT, SHE WOKE UP WITH A SEVERE BURNING ON HER NOSE UNDER THE STRIP. SHE REPORTED THAT WHERE THE STRIP ADHERED SHE HAD A RASPBERRY RED, BLISTER-LIKE BURNING LESION. SHE STATED, "I LIVED IN PHYSICAL PAIN FROM THE BURNING SENSATION, REMAINING UNCHANGED IN APPEARANCE, FOR MONTHS. THE BURNING LESION DISAPPEARED FOR A FEW WEEKS, BUT HAS NOT REAPPEARED." SHE STATED THAT "THE LATEST DERMATOLOGISTS" SAID THAT SHE COULD NO LONGER BE EXPOSED TO THE SUN AND MUST WEAR A SPECIAL 70 + SUNSCREEN ALL THE TIME. SHE STATED, "I WAS ALSO INFORMED THAT THIS WOULD NEVER PERMANENTLY HEAL." SHE REPORTED THAT IT CAN DISAPPEAR AND REAPPEAR AT ANY GIVEN MOMENT AND REMAIN FOR ANY LENGTH OF TIME. SHE STATED THAT THE PRODUCT HAS CAUSED HER A TREMENDOUS AMOUNT OF ACHES, TEMPORARY AND PERMANENT LIMITATIONS ON ACTIVITY AND DISFIGUREMENT. SHE STATED THAT SHE IS A DENTIST, AND SHE IS UNABLE TO WEAR HER LIGHTED MICROSCOPE GLASSES BECAUSE THE NOSEPIECE IS TOO PAINFUL RESTING ON THE LESION FROM THE PRODUCT. SHE STATED, "THE PHYSICAL PAIN AND DISFIGUREMENT IS NOT ALL THAT I SUFFER FROM, THE EFFECTS OF THIS HAS CAUSED AN IMPACT ON MY DAILY LIFE, FUNCTIONAL, SLEEP, APPETITE, RELATIONSHIPS WITH OTHERS, EMOTIONS, CONCENTRATIONS, ETC." SHE STATED THAT PHYSICIANS WERE UNABLE TO CONFIDENTLY DIAGNOSE THE CONDITION. SHE STATED THAT APPLICATION OF HYDROCORTISONE CREAM TO THE AREA, AND PAIN MEDICATION FOR THE BURNING WAS THE ONLY TREATMENT RECOMMENDED. SHE STATED THAT TAKING PROLONGED PAIN MEDICATIONS CAUSES HER TO WORRY THAT IT WILL LEAD TO ITS OWN SET OF CONSEQUENTIAL PROBLEMS. BREATHE RIGHT NASAL STRIPS ADVANCED ARE MANUFACTURED IN (B)(4), AND THE LOT NUMBER FOR THIS PRODUCT IS 3437UU6799191. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE BLISTER IN A (B)(6) FEMALE PT WHO RECEIVED BREATHE RIGHT NASAL STRIPS ADVANCED FOR AN UNK DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED BREATHE RIGHT NASAL STRIPS. ON (B)(6) 2014, THE PT EXPERIENCED APPLICATION SITE BLISTER, APPLICATION SITE SWELLING AND ADHESIVE TAPE ALLERGY. TREATMENT WITH BREATHE RIGHT NASAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. CONSUMER REPORTED SINCE (B)(6) 2014 AFTER USING THE PRODUCT SHE HAS EXPERIENCED BLISTERING AND SWELLING OF HER NOSE. CONSUMER REPORTED SHE MAY BE ALLERGIC TO THE ADHESIVE ON THE STRIP. CONSUMER REPORTED SHE MAY BE ALLERGIC TO THE ADHESIVE ON THE STRIP. CONSUMER REPORTED SHE SAW A DOCTOR AND THE DOCTOR ADVISED HER TO CONTACT GSK TO SEE WHAT TYPE OF ADHESIVE IS IN THE PRODUCT. AT THE TIME OF THIS REPORT THE EVENTS HAVE NOT RESOLVED. AE FOLLOW UP INFO RECEIVED (B)(6) 2014: CONSUMER CALLED AND REPORTED THE EVENTS OF SKIN RAISED AT APPLICATION SITE AND BUBBLED AT APPLICATION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358950 BREATHE RIGHT NASAL STRIPS ADVANCED BREATHE RIGHT NASAL STRIPS LWF GLAXOSMITHKLINE NA 3437UU6799191

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other UNSPECIFIED MEDICATIONS