MAUDE Adverse Event Report: WEBTEC A DIVISION OF SCARPA HEALTHCARE BREATHE RIGHT NASAL STRIPS EXTRA CLEAR

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), breathe right nasal strips extra clear.

Event Description

I tolerate the clear well.I am addicted to them (breathe right nasal strips extra clear) [addiction] case description: this case was reported by a consumer and described the occurrence of addiction in a male patient who received breathe right nasal strips (breathe right nasal strips extra clear) nasal strip (batch number unk, expiry date unknown) for difficulty breathing.Co-suspect products included breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number unk, expiry date unknown) for difficulty breathing.Concurrent medical conditions included hyperesthesia.Concomitant products included no therapy.On an unknown date, the patient started breathe right nasal strips extra clear and breathe right nasal strips tan.On an unknown date, an unknown time after starting breathe right nasal strips extra clear and breathe right nasal strips tan, the patient experienced addiction (serious criteria gsk medically significant), application site reaction, application site redness and application site irritation.Breathe right nasal strips extra clear was discontinued (dechallenge was negative).Breathe right nasal strips tan was discontinued (dechallenge was negative).On an unknown date, the outcome of the addiction, application site reaction, application site redness and application site irritation were not recovered/not resolved.The reporter considered the addiction to be related to breathe right nasal strips extra clear.The reporter considered the application site reaction, application site redness and application site irritation to be related to breathe right nasal strips tan.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was received on 27 september 2017.Consumer reported that "breathe right, clear, l, 30 ct.I use them every night.Three stores do not have it anymore.They do not have shelf space for it any longer.The tan ones irritates my sensitive nose.It makes more indentations and i wake up to a red nose.I tolerate the clear well.I am addicted to them".

Manufacturer Narrative

This report is associated with argus case (b)(4), breathe right nasal strips extra clear.

Event Description

I tolerate the clear well.I am addicted to them (breathe right nasal strips extra clear) [addiction].It makes more indentations [application site reaction].He did not use water [wrong technique in device usage process].Case description: this case was reported by a consumer and described the occurrence of addiction in a male patient who received breathe right nasal strips (breathe right nasal strips extra clear) nasal strip (batch number unk, expiry date unknown) for difficulty breathing.Co-suspect products included breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number unk, expiry date unknown) for difficulty breathing.Concurrent medical correlated to nditions included hyperesthesia.Concomitant products included no therapy.On an unknown date, the patient started breathe right nasal strips extra clear and breathe right nasal strips tan.On an unknown date, an unknown time after starting breathe right nasal strips extra clear and breathe right nasal strips tan, the patient experienced addiction (serious criteria gsk medically significant), application site reaction, application site redness and application site irritation.Breathe right nasal strips extra clear was discontinued (dechallenge was negative).Breathe right nasal strips tan was discontinued (dechallenge was negative).On an unknown date, the outcome of the addiction, application site reaction, application site redness and application site irritation were not recovered/not resolved.The reporter considered the addiction to be related to breathe right nasal strips extra clear.The reporter considered the application site reaction, application site redness and application site irritation to be related to breathe right nasal strips tan.Additional details, adverse event information was received on 27 september 2017.Consumer reported that "breathe right, clear, l, 30ct.I use them every night.Three stores do not have it anymore.They do not have shelf space for it any longer.The tan ones irritates my sensitive nose.It makes more indentations and i wake up to a red nose.I tolerate the clear well.I am addicted to them".Follow up information was received on 18 october 2017.Consumer reported for breathe right nasal strips tan large.The consumer reported when he pull these off, it pulls skin fibers off.The consumer no longer has this product and for breathe right nasal strips clear large.The consumer reported when he took this product off this morning, it left an indentation line on his nose.He did not use water for both products.On an unknown date, the outcome of application site peeling and wrong technique in device usage process was unknown.The reporter considered application site peeling breathe right nasal strips tan and application site redness related to breathe right nasal strips extra clear.It was unknown if the reporter considered the wrong technique in device usage process to be related to breathe right nasal strips extra clear and breathe right nasal strips tan.Follow-up information was received on 19 october 2017 from the patient in response to a request for permission to contact the healthcare provider.The patient denied permission to contact the physician and noted "there is no doctor involved.I called to find out why (redacted names of pharmacies) no longer carry the large, clear breathright strips which i use daily.".

• Brand Name: BREATHE RIGHT NASAL STRIPS EXTRA CLEAR
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): WEBTEC A DIVISION OF SCARPA HEALTHCARE; 5900 middle view way; knoxville TN 37909
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6905307
• MDR Text Key: 87853030
• Report Number: 2320643-2017-00009
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 10/18/2017
• 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: 81 YR