MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-09 for BREATHE RIGHT NASAL STRIPS CLEAR manufactured by Webtec A Division Of Scarpa Healthcare.
[91750740]
2320643-2017-00010 is associated with argus case (b)(4), breathe right nasal strips clear.
Patient Sequence No: 1, Text Type: N, H10
[91750741]
Breatherite clear has given me a serious skin irritation across the bridge of my nose wherever the strip touched/ on (b)(6) 2017 that her nose was raw in some areas [application site irritation]. On (b)(6) 2017 that her nose became really 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) -year-old female patient who received breathe right nasal strips (breathe right nasal strips clear) nasal strip (batch number 50946htc17, expiry date unknown) for product used for unknown indication. Concurrent medical conditions included allergy to plants (allergic to poison ivies). Concomitant products included no therapy. On (b)(6) 2017, the patient started breathe right nasal strips clear. On (b)(6) 2017, 1 days after starting breathe right nasal strips clear, the patient experienced application site irritation (serious criteria other: per reporter) and application site redness. The patient was treated with aloe barbadensis (aloe vera). On an unknown date, the outcome of the application site irritation and application site redness were unknown. The reporter considered the application site irritation to be related to breathe right nasal strips clear. It was unknown if the reporter considered the application site redness to be related to breathe right nasal strips clear. Additional details, adverse event information was received via email on (b)(6) 2017. Consumer reported that "my recent box of breathe right clear has given me a serious skin irritation across the bridge of my nose wherever the strip touched. This was worse than any irritation from when i used the stronger strips in the past. I am not allergic to adhesives or anything else that i know of except poison ivies". Follow up information was received on (b)(6) 2017. Consumer reported that she started using the product on (b)(6) 2017. She stated that on (b)(6) 2017 her nose became really red and was raw in some areas. Consumer stated she used aloe vera to help heal her nose. She stopped using the nasal strips on (b)(6) 2017. Initial and follow up information was included in above narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00010 |
| MDR Report Key | 7015553 |
| Report Source | CONSUMER |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2017-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT NASAL STRIPS CLEAR |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-11-09 |
| Lot Number | 50946HTC17 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEBTEC A DIVISION OF SCARPA HEALTHCARE |
| Manufacturer Address | 5900 MIDDLE VIEW WAY KNOXVILLE TN 37909 US 37909 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-09 |