MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-25 for BREATHE RIGHT NASAL STRIPS EXTRA CLEAR manufactured by Webtec Div Of Scarpa Healthcare.
[125018888]
The report # 2320643-2018-00005 is associated with (b)(4), breathe right nasal strips extra clear.
Patient Sequence No: 1, Text Type: N, H10
[125018949]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2018-00005 |
| MDR Report Key | 8005176 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-25 |
| Date of Report | 2014-02-24 |
| Date Mfgr Received | 2018-10-03 |
| Date Added to Maude | 2018-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT NASAL STRIPS EXTRA CLEAR |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-10-25 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEBTEC DIV OF SCARPA HEALTHCARE |
| Manufacturer Address | KNOXVILLE TN 37909 US 37909 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-25 |