MAUDE Adverse Event Report: GLAXOSMITHKLINE BREATHE RIGHT NASAL STRIPS EXTRA

Lot Number 263602XXK10

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099); Cancer (3262)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of basal cell carcinoma in a (b)(6) female patient who received breathe right nasal strips (breathe right nasal strips advanced) for an unk drug indication.A physician or other health care professional has not verified this report.Co-suspect medication included breathe right nasal strips extra.On an unk date in 2000, the patient started the advanced and extra variants of breathe right nasal strips.At an unk time after starting the variants of breathe right nasal strips, the patient experienced basal cell carcinoma and application site hemorrhage.This case was assessed as medically serious by gsk.Treatment with the variants of breathe right nasal strips was discontinued.At the time of reporting, the events were unresolved.Consumer has been using breathe right advanced and breathe right extra since the year 2000.She discontinued using breathe right advanced and breathe right extra about a year ago because the area on her left nostril began to bleed, so she went for a biopsy.She has been diagnosed with ae-basal cell carcinoma on her left nostril.Multiple lost codes.

Manufacturer Narrative

Breathe right nasal strips are manufactured in (b)(4) in the united states.The lot number for this product is available; however, it is unk whether the product will be returned for quality assurance testing.(b)(4).

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA
• Type of Device: BREATHE RIGHT NASAL STRIPS
• Manufacturer (Section D): GLAXOSMITHKLINE; research triangle park NC 27709
• Manufacturer (Section G): WEBTEC; 5900 middle view way; knoxville TN 37909
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4121390
• MDR Text Key: 18039970
• Report Number: 2320643-2014-00007
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 263602XXK10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• 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: 63 YR