MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-05-31 for BREATHE RIGHT NASAL STRIPS TAN manufactured by Webtec A Division Of Scarpa Healthcare.
[76301145]
This report is associated with argus case (b)(4), breathe right nasal strips tan.
Patient Sequence No: 1, Text Type: N, H10
[76301146]
Skin becomes different/n blood underneath skin/ marks [hemorrhage subcutaneous]. Nose becomes bigger [nasal disorder]. Case description: this case was reported by a consumer via call center representative and described the occurrence of skin disorder in a (b)(6) male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number 491408645570, expiry date unknown) for nasal congestion. Concomitant products included breathe right nasal strips (breathe right nasal strips clear). On an unknown date, the patient started breathe right nasal strips tan. On an unknown date, an unknown time after starting breathe right nasal strips tan, the patient experienced skin disorder and nasal disorder. On an unknown date, the outcome of the skin disorder and nasal disorder were not recovered/not resolved. It was unknown if the reporter considered the skin disorder and nasal disorder to be related to breathe right nasal strips tan. Additional details, consumer was using the product for 1 week now at my nose. He noticed my skin becomes different. My nose becomes bigger. And he found out there's blood underneath my skin. Before, he used the plastic one (clear) (breathe right nasal strips clear), it was good. The action taken od breathe right nasal strips clear was unknown. Follow up received on 08 may 2017. On an unknown date, the outcome of the skin disorder and nasal disorder were recovering/resolving. His nose was starting to recover. He went doctor and she told that he was allergic to the tan strips. He got the clear one now, he had it replaced at (b)(6) pharmacy. There's no more blood, no more marks. She gave some kind of cream to rub on nose. Follow up was received on 22 may 2017, this case was reported by a physician and described the occurrence of subcutaneous bleeding in a (b)(6) male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number 491408645570, expiry date unknown) for nasal congestion. Concurrent medical conditions included drug allergy. On an unknown date, an unknown time after starting breathe right nasal strips tan, the patient experienced subcutaneous bleeding (serious criteria gsk medically significant) and nasal disorder. On an unknown date, the outcome of the subcutaneous bleeding and nasal disorder were recovering/resolving. The reporter considered the subcutaneous bleeding and nasal disorder to be almost certainly related to breathe right nasal strips tan.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00005 |
| MDR Report Key | 6601939 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-01 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-05-31 |
| 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 TAN |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-05-31 |
| Lot Number | 491408645570 |
| Operator | LAY USER/PATIENT |
| 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 | 2017-05-31 |