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

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problems Seizures (2063); Convulsion/Seizure (4406)

Event Type  malfunction  

Manufacturer Narrative

Argus case (b)(4).

Event Description

He had 3 seizures in 11 months.This would only happen while he sleeping on his back.[seizure] case description: this case was reported by a consumer and described the occurrence of seizure in a (b)(6) old male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number g1377764, expiry date unknown) for difficulty breathing.This case was associated with a product complaint.Co-suspect products included breathe right nasal strips (breathe right nasal strips clear) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing, breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing, breathe right nasal strips (breathe right lavender nasal strips) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing and breathe right nasal strips nasal strip (batch number unknown, expiry date unknown) for difficulty breathing.On an unknown date, the patient started breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips.On an unknown date, an unknown time after starting breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips, the patient experienced seizure (serious criteria gsk medically significant) and product complaint.The action taken with breathe right nasal strips tan was unknown.The action taken with breathe right nasal strips clear was unknown.The action taken with breathe right nasal strips extra was unknown.The action taken with breathe right lavender nasal strips was unknown.The action taken with breathe right nasal strips was unknown.On an unknown date, the outcome of the seizure and product complaint were unknown.It was unknown if the reporter considered the seizure to be related to breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Adverse event information was received on 26 november 2019.Consumer reported that, "if you needed someone for advertisement.He had 3 seizures in 11 months.This would only happen while he sleeping on his back.He did we got some that wouldn't stick.I wondered if you did something different that these last two boxes didn't stick.He has been using these for almost 12 years for almost 24 hours a day.Unless he's in the car or some where with air conditioning on.He has tried the clear, extra strength and the lavender.The only one that worked was the original.".

Event Description

Case description: this case was reported by a consumer and described the occurrence of seizure in a 83-year-old male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number g1377764, expiry date unknown) for difficulty breathing.This case was associated with a product complaint.Co-suspect products included breathe right nasal strips (breathe right nasal strips clear) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing, breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing, breathe right nasal strips (breathe right lavender nasal strips) nasal strip (batch number unknown, expiry date unknown) for difficulty breathing and breathe right nasal strips nasal strip (batch number unknown, expiry date unknown) for difficulty breathing.On an unknown date, the patient started breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips.On an unknown date, an unknown time after starting breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips, the patient experienced seizure (serious criteria gsk medically significant) and product complaint.The action taken with breathe right nasal strips tan was unknown.The action taken with breathe right nasal strips clear was unknown.The action taken with breathe right nasal strips extra was unknown.The action taken with breathe right lavender nasal strips was unknown.The action taken with breathe right nasal strips was unknown.On an unknown date, the outcome of the seizure and product complaint were unknown.It was unknown if the reporter considered the seizure to be related to breathe right nasal strips tan, breathe right nasal strips clear, breathe right nasal strips extra, breathe right lavender nasal strips and breathe right nasal strips.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received on 26 november 2019.Consumer reported that, "if you needed someone for advertisement.He had 3 seizures in 11 months.This would only happen while he sleeping on his back.He did we got some that wouldn't stick.I wondered if you did something different that these last two boxes didn't stick.He has been using these for almost 12 years for almost 24 hours a day.Unless he's in the car or some where with air conditioning on.He has tried the clear, extra strength and the lavender.The only one that worked was the original".Follow up information was received on 26 november 2019 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for lot number g1377764.The investigation reports concluded that, complaint stands unsubstantiated.Complaint sample not received at investigation site.Analysis and strip stability review prior to release of any lot of breathe right strips, laboratory testing is performed on the adhesive strength of a random sample.The result of the testing is verified to be within product specifications for the type of strip tested.This regular testing will proactively identify any inadequate adhesive value prior to release of any product to market.There have not been any stability failures with these strips.Each complaint received for "lack of adhesion" will be triaged and assessed for closure with this document, it will then be monitored to identify any developing trends with respect to the product and/or lot numbers in accordance with local procedure.Should a trend be identified, further investigation will be required."lack of adhesion" complaints do not impact the product's quality, safety or efficacy and require no further actions by our contractor or laboratories, unless a trend or an alert limit is triggered.

Manufacturer Narrative

Mfr #: 2320643-2019-00010 is associated with argus case (b)(4).

• Brand Name: BREATHE RIGHT NASAL STRIPS
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC DIV OF SCARPA HEALTHCARE; knoxville TN
• MDR Report Key: 9509613
• MDR Text Key: 196102631
• Report Number: 2320643-2019-00010
• Device Sequence Number: 1
• Product Code: LWF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR