MAUDE Adverse Event Report: FOUNDATION CONSUMER BRANDS, LLC BREATHE RIGHT CLEAR SMALL/MEDIUM 30 CT.; NASAL STRIPS

Lot Number 1294737

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cellulitis (1768); Peeling (1999); Skin Burning Sensation (4540); Contact Dermatitis (4546)

Event Date 12/31/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated and is ongoing, results are not yet available.It should also be noted that the consumer did not follow instructions for removal of the product (user error).This report is made by fch without prejudice and does not imply any admission or liability for the incident or its consequences.

Event Description

On 03-jan-2023, a spontaneous report from the united states was received via email regarding a 67-year-old female who used a breathe right clear nasal strip.Medical history included hypertension and high cholesterol.The consumer previously used breathe right clear nasal strips once to twice a year for cold symptoms.The consumer had a cold in (b)(6) 2022 and used the product on (b)(6) 2022 and (b)(6) 2022 without event.The consumer was allergic to "tetanus" and sulfa (sulfonamides).On 29-dec-2022, the consumer applied a breathe right clear nasal strip for a cold.On 05-jan-2023, additional information was received from a consumer.On 03-jan-2023, the consumer reported that she used a breathe right clear nasal strip on (b)(6) 2023.After waking up she noticed that her face was swollen and felt as though it was "on fire".The consumer used a temporal thermometer to measure the temperature of her cheeks as they felt like 104 degrees and it measured 106.9 degrees fahrenheit.However, when she took her temporal temperature, it was normal.(b)(6) 2023, it was clarified that she applied the product the night of (b)(6) 2022 and then she went to bed.She woke up (b)(6) 2022, and gently peeled the strip off without using water.Immediately her face and nose were red and inflamed.Subsequently, she discontinued the strips.The consumer reported facial swelling accompanied by difficulty opening her mouth.She also reported periorbital edema and intense burning.She called her doctor and was advised to immediately go to an urgent care or an emergency room.At an urgent care she was diagnosed with contact dermatitis and facial cellulitis.She was given an unspecified oral steroid and sent home with prednisone at twice daily for 5 days, cephalexin at 500 mg three times a day for 10 days, and zyrtec (cetirizine) at 10 mg daily.On (b)(6) 2023, her face started to peel.She used cocoa butter to the area which she felt was helping.She wondered if she might have used expired nasal strips, but she could not locate an expiration date.She thought she had them for a few years, maybe longer, but she was not sure.As of 05-jan-2023, she noted she had been taking her prescriptions as directed and her symptoms had not completely resolved but were 90% better.No additional information was provided.

Manufacturer Narrative

On 03-apr-2023, the device evaluation was completed.The updated manufacturer narrative is as follows: the complaint sample was evaluated, and no issues noted.Test results confirm retain samples from the same lot met specifications and no issues were observed during the manufacturing of this lot.This report is made by fch without prejudice and does not imply any admission or liability for the incident or its consequences.

Event Description

On 16-mar-2023 additional information was received from a consumer.On 03-apr-2023, the device evaluation was completed.On 16-mar-2023, it was further clarified that on (b)(6) 2022, when she removed the nasal strip, it hurt and she noticed her nose was red and irritated.On (b)(6) 2022, upon awakening, her face felt as if it was on fire.Her nose and cheeks were puffy, bright red, eyes were little slits, and she barely could open her mouth to brush her teeth.The pain and burning sensation of the face increased.She applied ice that helped for a few minutes.The same day ((b)(6) 2022), she drove to urgent care where she was given oral steroids to drink.The discharge prednisone dosage was clarified to be prednisone 20 mg at 2 tablets once daily for 5 days starting on (b)(6) 2023.After the urgent care visit, she was in a lot of pain but after a couple of weeks the pain, redness, and swelling subsided.Her face itched, blistered, and peeled.After she completed her medications, the skin on her cheeks and nose was a little rosy, hurt, and dry but she looked back to normal.

• Brand Name: BREATHE RIGHT CLEAR SMALL/MEDIUM 30 CT.
• 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: 16269291
• MDR Text Key: 308440860
• Report Number: 3010200299-2023-00002
• 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,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1294737
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; LISINOPRIL
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 91 KG