MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-12-12 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[94510338]
This report is associated with (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[94510339]
Sudden on set serious irritation with the breathe right nasal strips [skin irritation]. Case description: this case was reported by a other health professional and described the occurrence of skin irritation in a patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips. On an unknown date, an unknown time after starting breathe right nasal strips, the patient experienced skin irritation (serious criteria other: as per reporter). On an unknown date, the outcome of the skin irritation was unknown. The reporter considered the skin irritation to be related to breathe right nasal strips. This adverse event information was received via mail on 04 december 2017. He mentioned that he has had a lot of people suddenly complaining about sudden on set serious irritation with the breathe right nasal strips. He did not thought this was coincidental. There must be some change to the adhesive component, whether it be a different chemical or a different manufacturer of the chemicals that make up the adhesive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00011 |
| MDR Report Key | 7108186 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-04 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2017-12-12 |
| 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 |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-12-12 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-12-12 |