MAUDE Adverse Event Report: FOUNDATION CONSUMER BRANDS, LLC BREATHE RIGHT TAN NASAL STRIP; NASAL STRIPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Localized Skin Lesion (4542)

Event Date 01/01/2012

Event Type  Injury  

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via email regarding a female (age not provided) consumer who used a breathe right tan nasal strip.Approximately 10 years ago (reported as she originally thought it was 5 years ago, but it felt it was more like 10 years ago; in-regards to (b)(6) 2022), she used a breathe right tan nasal strip on a nightly basis for approximately one week for an unspecified indication.Consumer discontinued use of the product and has not used it since.The consumer had no underlying medical conditions and did not use any concomitant products.After a week of using the product, she said she had a bad reaction to the strips.It was clarified that she noticed a growth on the side of her nose where the strip had been placed."it was a giant growth on the corner of her nose." the growth was flesh colored and about the size of a large pea.Subsequently, she discontinued use of the product and made a dermatologist appointment.She had the growth removed surgically, in an out-patient setting, three different times approximately over a three-year span of time.On an unspecified date in 2012, she visited a dermatologist and had a shave procedure to remove a portion of the growth.The growth was tested, but she could not remember the pathology, but it was "something that grows back easily".She had several more shave procedures done, until most of the growth had been removed.Approximately one year later, the growth returned.Subsequently, she went to another dermatologist who surgically removed the whole growth.She noted it would do okay for one year and then the growth would return.She noted she had to have a total of 5 surgeries, and it kept growing back.Several years later, she sought care with another dermatologist who used cortisone injections to the area.She thought she received one injection per month for three months.The injections did the best job of shrinking down the growth, kept it from returning, and finally cleared it away.The consumer reported that several of the dermatologist that she had seen felt it was some sort of allergic reaction to the nasal strips, that caused the growth to occur.As of (b)(6) 2022, she stated she still had a very small growth remaining which was about the size of a half of a pea.Her dermatologist informed her that if any further injections are provided the area may become concave.She stated it was much less noticeable than the original growth as that was very unsightly.No additional information was provided.

Manufacturer Narrative

The complainant states the reported event occurred over 10 years ago and does not remember what breathe right tan nasal strip was used.Complainant used the product for approximately one week and has not used the product since.No investigation can be conducted since no product is available.This report is made by fch without prejudice and does not imply any admission or liability for the incident or its consequences.

• Brand Name: BREATHE RIGHT TAN NASAL STRIP
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): FOUNDATION CONSUMER BRANDS, LLC; 106 isabella street, suite 602; pittsburgh PA 15212
• Manufacturer (Section G): FOUNDATION CONSUMER BRANDS, LLC; 106 isabella street, suite 602; pittsburgh PA 15212
• Manufacturer Contact: 106 isabella street, suite 602; pittsburgh, PA 15212 ; 4125332442
• MDR Report Key: 16205173
• MDR Text Key: 307690604
• Report Number: 3010200299-2023-00001
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female