MAUDE Adverse Event Report: FOUNDATION CONSUMER BRANDS, LLC BREATHE RIGHT EXTRA CLEAR; NASAL STRIPS

Lot Number 1646551

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

Patient Problem Cellulitis (1768)

Event Date 10/08/2022

Event Type  Injury  

Manufacturer Narrative

This report is made by fch without prejudice and does not imply any admission or liability for the incident or its consequences.Investigation has been initiated and is on-going, results are not yet available.

Event Description

On (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 73-year-old female who used a breathe right extra clear nasal strip.Medical history included atrial fibrillation and hypothyroidism.The consumer did not have any known drug allergies.Concomitant products included synthroid (levothyroxine), zocor (simvastatin), prilosec (omeprazole), metoprolol, and eliquis (apixaban).The consumer did not smoke and denied use of any vitamins or supplements.On an unspecified date in (b)(6) 2022, about a week prior (relative to (b)(6) 2022) the consumer topically applied a breathe right extra clear nasal strip at night.On (b)(6) 2022, additional information was received from the consumer.After applying the nasal strip, she noticed an improvement in her snoring, and she continued use of the product.Approximately on the 4th night of use of the nasal strips, she woke up in the middle of the night with an uncomfortable feeling on her face.She looked in the mirror and noticed that her left eyelid was swollen.Subsequently, she took benadryl (diphenhydramine) which did not help.She was on vacation and went to a local urgent care and she was diagnosed with periorbital cellulitis.She was prescribed clindamycin.The urgent care staff noted that she might have been bitten by something or had a small scratch that possibly was infected by bacteria.The swelling had spread to the left side of her face at the time she presented to the urgent care.On an unspecified date in (b)(6) 2022, she contacted her regular ophthalmologist, and he switched the antibiotic to doxycycline since it was gentle on the stomach.He also scheduled her for an emergency appointment for the next monday.At the appointment, she brought the product with her.The doctor was not confident that her cellulitis was due to a product allergy related since she was responding to the antibiotic.He believed it was a bacterial infection but was not 100% sure.The swelling was minimal at the time she presented to her ophthalmologist, and she noted the doctor was not too concerned.The consumer was scared to continue the product because of her experience.She noted she had a good response from using the product, and thought the swelling was coincidental, but was afraid to continue.On (b)(6) 2022, the consumer had an appointment with an ophthalmologist who informed the consumer that the infection was definitely bacterial as the doxycycline had completely cleared all of the symptoms, other than some dryness to her eyelid.He also wanted to prevent an infection in the area and therefore prescribed neomycin/polymyxin ointment to be used for 7 days.On (b)(6) 2022, the consumer noted her eye was clearing up with the use of the prescribed antibiotic.The consumer felt the dryness has completely resolved as of (b)(6) 2022.Consumer's ophthalmologist did not feel that the product played any role in consumer developing the cellulitis.Consumer stated she loves the product and would like to try it again in the future, with the ok from her doctor.No additional information was provided.

Manufacturer Narrative

This report is made by fch without prejudice and does not imply any admission or liability for the incident or its consequences.Investigation has been initiated and is on-going, results are not yet available.On 29-dec-2022, the investigation was completed.The investigation results follow: fch opened an investigation, test results confirmed no issues with complaint sample.Review of manufacturing records showed lot met specifications and no issues were observed during the manufacturing of this lot.The consumer reported that their ophthalmologist informed her that the infection was definitely bacterial and did not feel that the product played any role in consumer developing the cellulitis.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 EXTRA CLEAR
• 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: 15730686
• MDR Text Key: 303042812
• Report Number: 3010200299-2022-00002
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 1646551
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ELIQUIS (APIXABAN); METOPROLOL; PRILOSEC (OMEPRAZOLE); SYNTHROID (LEVOTHYROXINE); ZOCOR (SIMVASTATIN)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 86 KG