MAUDE Adverse Event Report: GLAXOSMITHKLINE BREATHE RIGHT NASAL STRIPS

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Cancer (3262)

Event Date 09/10/2014

Event Type  Injury  

Event Description

Have used breathe right nasal strips for 10 years.Reported difficulty of removing adhesive from skin to glaxosmithkline who recommended use of mineral oil, baby oil, alcohol prep.Continue use for years as product did help night breathing.In 10th year of use (2013) skin of external left nostril broke open bleeding.Dermatologist cauterized area.Same thing happened about a year later 2014.Biopsy taken.Basal cell skin cancer pending moh's surgery.Over the 10 years of using the breathe right nasal strips i primarily used the clear, original brand but also occasionally bought other varieties of nose strips by glaxosmithkline when the preferred original clear variety were not available at purchase site.I used the strips every night for ten years until break open bleeding of the skin on the left nostril occurred in the 10th year.I have not used the product since the bleeding started which is a year now.

• Brand Name: BREATHE RIGHT NASAL STRIPS
• Type of Device: BREATHE RIGHT NASAL STRIPS
• Manufacturer (Section D): GLAXOSMITHKLINE
• MDR Report Key: 4189946
• MDR Text Key: 15328899
• Report Number: MW5038674
• Device Sequence Number: 1
• Product Code: LWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 76