MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS EXTRA CLEAR

Lot Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anaphylactic Shock (1703); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Emotional Changes (1831); Erythema (1840); Unspecified Infection (1930); Rash (2033); Skin Discoloration (2074); Swelling (2091); Burning Sensation (2146); Anxiety (2328); Deformity/ Disfigurement (2360); Chest Tightness/Pressure (2463); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The report # 2320643-2018-00005 is associated with (b)(4), breathe right nasal strips extra clear.

Event Description

Application site infection [application site infection]; i had an anaphylactic reaction.[anaphylactic reaction]; application site blister [application site blister]; my face swelled up where the strip initially was applied 4 years ago and i had an anaphylactic reaction.[application site swelling]; adhesive tape allergy [adhesive tape allergy]; skin raised at application site [application site reaction]; application site redness [application site redness]; discoloration of skin at application site [application site discoloration]; burning sensation at application site [application site burning]; disfigurement [disfigurement]; sleep changes [sleep disorder]; change in appetite [appetite disorder]; altered concentration [concentration impaired]; dysfunction of daily living activities [activities of daily living impaired]; emotional changes [emotional disorder]; worry/open my lungs back up, so i could breathe again but i almost died [anxiety]; reduced activity [decreased activity]; chest tightened up [chest tightness]; i had an allergic reaction to this strips a few years ago [allergic reaction]; the rash is still there from the breathe right strip [application site rash]; my chest tightened up and they had to give me medication to open my lungs back up so i could breathe again [difficulty breathing]; t cell disorder [ill-defined disorder].Case description: this case was reported by a consumer and described the occurrence of application site blister in a (b)(6) year-old female patient who received breathe right nasal strips (breathe right nasal strips advanced) for an unknown drug indication.A physician or other health care professional has not verified this report.On an unknown date, the patient started breathe right nasal strips.On (b)(6) 2014, the patient 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 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 information received (b)(6) 2014: consumer called and reported the events of skin raised at application site and bubbled at application site.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 information was received via mail on (b)(6) 2014.The dentist (who is the patient) 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 now 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, function, 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.The manufacturer's report number for this case is 2320643-2014-00004.Breathe right nasal strips advanced are manufactured in (b)(4), and the lot number for this product is 3437uu6799191.Adverse event information was receive on 03-october-2018 via call.The consumer reported for breathe right nasal strips sensitive skin 26ct clear strips.The consumer stated that, "i had an allergic reaction to this strips a few years ago and this is my second reaction.I have the case number from when it happened.It came back and i believe is very important to have the company involved since i almost die, so no one dies.I am trying to find out how the company can help me with my medical bills.My face swelled up where the strip initially was applied 4 years ago and i had an anaphylactic reaction.My chest tightened up and they had to give me medication to open my lungs back up, so i could breathe again, but i almost died.The rash is still there from the breathe right strip and i saw my dermatologist just now and it cost me (b)(6) dollars to see him.I have to get an special kind of epi-pen that cost (b)(6) dollars and i have to shoot myself if it pops back again at any time because since the breathe right nasal strips initially caused this, the problem with the t cells whatever that means, he told me that i would have a problem with this for the rest of my life.This pops up out of the blue for no reason.So, now i'm freaked out because now i know that it can pop up at any time and i have to carry an epi-pen to shoot myself when it happens again.I have to get a list of everything that is in this breathe right strips because all i can do on my end is to have a patch test done to see what exactly is in the breathe right strips that has caused me to be allergic to.I need to get the list of ingredient in this product.I need to know what i'm sensitive to.I want to let other people know about this because if i would have known if i've never done it.Something so simple, drug free can caused this reaction.Can you email me that information? lot 3437uu6719919 box." adverse event information was receive on 03-october-2018 via call.The consumer reported for breathe right nasal strips sensitive skin 26ct clear strips.The consumer stated that, "i had an allergic reaction to this strips a few years ago and this is my second reaction.I have the case number from when it happened.It came back and i believe is very important to have the company involved since i almost die, so no one dies.I am trying to find out how the company can help me with my medical bills.My face swelled up where the strip initially was applied 4 years ago and i had an anaphylactic reaction.My chest tightened up and they had to give me medication to open my lungs back up so i could breathe again, but i almost died.The rash is still there from breathe right strip and i saw my dermatologist just now and it cost me (b)(6) to see him.I have to get an special kind of epi-pen that cost (b)(6) dollars and i have to shoot myself if it pops back again at any time because since the breathe right nasal strips initially caused this, the problem with the t cells whatever that means, he told me that i would have a problem with this for the rest of my life.This pops up out of the blue for no reason.So, now i'm freaked out because now i know that it can pop up at any time and i have to carry an epi-pen to shoot myself when it happens again.I have to get a list of everything that is in this breathe right strips because all i can do on my end is to have a patch test done to see what exactly is in the breathe right strips that has caused me to be allergic to.I need to get the list of ingredient in this product.I need to know what i'm sensitive to.I want to let other people know about this because if i would have known if i've never done it.Something so simple, drug free can caused this reaction.Can you email me that information? lot 3437uu6719919 box." co-suspect product included breathe right nasal strips extra clear (primary lot unknown and secondary lot 3437uu6719919).Treatment drug included epi-penthe consumer had used the product for nasal congestion.The consumer experienced chest discomfort, hypersensitivity, application site rash, dispnoea, anxiety, ill-defined disorder.At the time of this report the events were not resolved.The reporter considered chest discomfort, hypersensitivity, application site rash, dyspnoea, anxiety, ill-defined disorder to be related to breathe right nasal strip advance and breathe right nasal strip extra clear.Case comment: 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 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.

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA CLEAR
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN 37909
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8005176
• MDR Text Key: 125018888
• Report Number: 2320643-2018-00005
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR