MAUDE Adverse Event Report: GLAXOSMITHKLINE BREATHE RIGHT NASAL STRIPS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Swelling (2091); Reaction (2414)

Event Type  Other  

Event Description

This case was reported by a consumer and described the occurrence of allergic reaction in a male pt who rec'd breathe right nasal strips strip for an unk drug indication.A physician or other health care professional has not verified this report.On an unk date, the pt started breathe right nasal strips (topical).At an unk time after starting breathe right nasal strips, the pt experienced allergic reaction, nasal erythema, swollen nose and nasal pain.She said he developed a nose infection.At the time of reporting, the outcome of the events was unk.Ae reported via voice mail: rptr stated that her husband had an adverse reaction to the nose strips.She stated that she did not known they were made of latex.Ae f/u rec'd 31 march 2014 which upgraded the case to serious: add'l adverse events of redness at application site, swelling at application site, pain at application site, nose infection and allergic reaction were reported.Rptr stated that her husband used breathe right clear small/medium size and experienced the events reported.She stated that he saw his dr about the events and was prescribed an unk antibiotic for the nose infection.This case was assessed as medically serious by gsk.Se is not certain if the nose infection is related to his use of breathe right.She provided medical history that her husband is allergic to latex.His age is reported to be (b)(6).Breathe right is manufactured in (b)(4) in the united states, and neither the product nor the lot number for this product is available.(b)(4).

• Brand Name: BREATHE RIGHT NASAL STRIPS
• 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: 3772103
• MDR Text Key: 21174732
• Report Number: 2320643-2014-00003
• 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: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• 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; ZINC; LUTEIN
• Patient Outcome(s): Other
• Patient Age: 65 YR