MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-07-21 for BREATHE RIGHT EXTRA (UNKNOWN) manufactured by Webtec A Division Of Scarpa Healthcare.
[50174986]
Report # 2320643-2016-00007 is associated with (b)(4), breathe right extra (unknown). Breathe right extra (unknown) is marketed as breathe right nasal strips in the u. S.
Patient Sequence No: 1, Text Type: N, H10
[50174987]
Application site bruise [application site bruise]. Case description: this case was reported by a consumer via call center representative and described the occurrence of application site bruise in a male patient who received breathe right nasal strips (breathe right extra (unknown)) nasal strip for an unknown indication. On (b)(6) 2016, the patient started breathe right extra (unknown). On an unknown date, less than a day after starting breathe right extra (unknown), the patient experienced application site bruise (serious criteria gsk medically significant). On an unknown date, the outcome of the application site bruise was unknown. It was not reported if the reporter considered the application site bruise to be related to breathe right extra (unknown). [clinical course]: on (b)(6) 2016, the patient developed bruise-like spot in the application site about one hour after he put breathe right extra (unknown).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2016-00007 |
| MDR Report Key | 5813518 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-14 |
| Date Mfgr Received | 2016-07-14 |
| Date Added to Maude | 2016-07-21 |
| 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 EXTRA (UNKNOWN) |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2016-07-21 |
| Device Availability | * |
| 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 | 2016-07-21 |