MAUDE Adverse Event Report: WEBTEC BREATHE RIGHT NASAL STRIPS ADVANCED

Lot Number 3437UU6799191

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Swelling/ Edema (4577)

Event Date 02/21/2014

Event Type  Injury  

Event Description

This case was reported by a consumer and described the occurrence of application site blister in a 44-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 25 february 2014: consumer called and reported the events of skin raised at application site and bubbled at application site.

Manufacturer Narrative

This report is being submitted retrospectively per fda request.Ae follow-up received on 27 february 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 06 june 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.G7 continued: 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].Reduced activity [decreased activity].

• Brand Name: BREATHE RIGHT NASAL STRIPS ADVANCED
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC; 5900 middle view way; knoxville TN 37909
• Manufacturer (Section G): GLAXOSMITHKLINE; po box 13398; research triangle park NC 27709
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8005163
• MDR Text Key: 316846643
• Report Number: 2320643-2018-00003
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

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: 3437UU6799191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• 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
• Patient Sex: Female