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

Lot Number 4489T8008440

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Peeling (1999); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Addicted to them [addiction].Application site raw/ imprint was really raw [application site irritation].Application site reaction/ had a really bad reaction to it/ noticed a perfect imprint [application site reaction] itch at application site/ it was kind of itchy [application site itching], peeling at application site/ it peeled enough/ started to peel like i had sunburn [application site peeling].Scab at application site/ it left a scab on my nose [application site scab] it was red [application site redness].Case description: this case was reported by a consumer and described the occurrence of application site irritation in a (b)(6) female patient who received breathe right nasal strips (breathe right nasal strips clear) nasal strip (batch number (b)(4), expiry date unknown) for snore.On (b)(6) 2016, the patient started breathe right nasal strips clear.On (b)(6) 2016, 3 days after starting breathe right nasal strips clear, the patient experienced application site irritation and application site reaction.On (b)(6) 2016, the patient experienced application site itching and application site peeling.On (b)(6) 2016, the patient experienced application site scab.Breathe right nasal strips clear was discontinued (dechallenge was positive).On (b)(6) 2016, the outcome of the application site irritation, application site reaction, application site itching and application site peeling were recovered/resolved.On (b)(6) 2016, the outcome of the application site scab was recovered/resolved.It was unknown if the reporter considered the application site irritation and application site reaction to be related to breathe right nasal strips clear.The reporter considered the application site itching, application site peeling and application site scab to be related to breathe right nasal strips clear.Additional details, the consumer reported that, "it was kind of itchy but it never hurt.It peeled enough that if left a scab on my nose.I used a different strip for three nights in a row and had a really bad reaction to it.After two days, my nose started to peel like i had sunburn.On the fourth night, i noticed a perfect imprint of where the strips were.The imprint was really raw." the adverse event revision received on 26 may 2016.About 2 years ago she used to use these all the time and she would had said she was addicted to them, she was obsessed with them, she was familiar with product she used it all the time, then it got kind of expensive so she stopped using them for a long time and then she got a sample in the mail, bought a box at a local store and she used one strip each night for 3 nights in a row and she had a really bad reaction to it and she never had a reaction to a breathe right before.She did not know if this could have been an old box.On the fourth night when she went to put a strip on she noticed across her nose a perfect imprint of the whole breathe right strip, she could see a red mark where the whole strip was so she didn't put a breathe right on and after about 2 days her nose started peeling, big flakes of skin and it peeled for almost a whole week like a sunburn and she got a scab across her nose.Did you change something? she did not know what happened with this box.It was kind of itchy, it never hurt, but where it was red it was itchy.The reporter considered the drug dependence and application site erythema to be related to breathe right nasal strips clear unknown batch number and given lot number respectively.

• Brand Name: BREATHE RIGHT NASAL STRIPS 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: 5692018
• MDR Text Key: 46315095
• Report Number: 2320643-2016-00005
• 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
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4489T8008440
• Date Manufacturer Received: 05/18/2016
• 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: 52 YR