MAUDE Adverse Event Report: WEBTEC DIV OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)

Event Type  No Answer Provided  

Event Description

This case was reported by a consumer and described the occurrence of anaphylactic shock in a female pt who received breathe right nasal strips for an unk indication.On an unk date, the pt started breathe right nasal strips.On an unk date, an unk time after starting breathe right nasal strips, the pt experienced anaphylactic shock (serious criteria gsk medically significant), unwell, allergy and difficulty breathing.The action taken with breathe right nasal strips was unk (de-challenge was unk).On an unk date, the outcome of the anaphylactic shock, unwell, allergy and difficulty breathing were unk.The reporter considered the anaphylactic shock, unwell, allergy and difficulty breathing to be related to breathe right nasal strips.Ae received 12 january 2015 via voice mail.The consumer reported via voicemail that her sister experienced the adverse events of unwell, anaphylactic question shock, allergy and difficulty breathing from using breathe right.She reported that her sister became very ill and they thought she was possibly going into anaphylactic shock.They were curious what the allergy could have been that caused her not to be able to breathe for a couple of hours.The consumer did not answer when phoned and no personal info was obtained for this report.

• Brand Name: BREATHE RIGHT NASAL STRIPS
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4440003
• MDR Text Key: 5310128
• Report Number: 2320643-2015-00001
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 01/12/2015
• 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