MAUDE Adverse Event Report: GLAXOSMITHKLINE BREATHE RIGHT NASAL STRIPS TAN

Lot Number 3564T6904930

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Skin Irritation (2076); Ulcer (2274); Tissue Breakdown (2681)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of application site ulcer in a (b)(6) female patient who received breath right nasal strips (breathe right nasal strips tan) for an unknown drug indication.A physician or other health care professional has not verified this report.Concurrent conditions include dry skin.On an unknown date, the patient started breathe right nasal strips.At an unknown time after starting breathe right nasal strips, the patient experienced application site ulcer which broke open (sore broke open) and bled (application site hemorrhage).The patient removed the strip without water (device misuse).This case was assessed as medically serious by gsk.Treatment with breathe right nasal strips was discontinued.At the time of reporting, the event of application site bleeding had resolved, the sore broke open had improved while the application site ulcer were unresolved.The consumer reported that when she used the breathe right tan for 3 days, she experienced a sore at the application site, the sore broke open at the application site and bled.The sore which is broke open has improved, but has not resolved.The bleeding resolved.The consumer also reported device misuse further explained as removing the strip dry.The consumer uses the clear product without any issues.She does have dry skin.

Manufacturer Narrative

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

• Brand Name: BREATHE RIGHT NASAL STRIPS TAN
• Type of Device: BREATHE RIGHT NASAL STRIPS
• Manufacturer (Section D): GLAXOSMITHKLINE; researcg 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: 3993494
• MDR Text Key: 4957400
• Report Number: 2320643-2014-00005
• 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: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3564T6904930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2014
• 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
• Treatment: GARLIC (UNK - UNK); LUTEIN (UNK - UNK); ZINC (UNK - UNK)
• Patient Outcome(s): Other
• Patient Age: 58 YR