MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-09-26 for BREATHE RIGHT NASAL STRIPS TAN manufactured by Webtec A Division Of Scarpa Healthcare.
[55609237]
This report is associated with argus case (b)(4), breathe right nasal strips tan.
Patient Sequence No: 1, Text Type: N, H10
[55609238]
Can't sleep without them [dependence]. Product availability issue. Case description: this case was reported by a consumer via call center representative and described the occurrence of dependence in a (b)(6) female patient who received breathe right nasal strips (breathe right nasal strips clear) nasal strip for nasal disorder and sleep unwell. Co-suspect products included breathe right nasal strips (breathe right nasal strips tan) nasal strip for nasal disorder and sleep unwell. On an unknown date, the patient started breathe right nasal strips clear and breathe right nasal strips tan. On an unknown date, an unknown time after starting breathe right nasal strips clear and breathe right nasal strips tan, the patient experienced dependence (serious criteria gsk medically significant) and product availability issue. On an unknown date, the outcome of the dependence and product availability issue were unknown. It was unknown if the reporter considered the dependence and product availability issue to be related to breathe right nasal strips clear and breathe right nasal strips tan. Additional details: the patent had been using breathe right strips clear variant and tan variant and for 22 years. She can't sleep without them. There's only one pharmacy in her town and was informed that the product was no longer made. The patient was informed that what were given to her were the last ones and i was told that it will be the last ones of both variants. The patient prefers the tan variant. The patient saw a doctor before she started using them. She was sent to a specialist to check if there was a problem but there was not anything that he could find.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2016-00010 |
| MDR Report Key | 5976693 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-09-26 |
| Date of Report | 2016-09-09 |
| Date Mfgr Received | 2016-09-09 |
| Date Added to Maude | 2016-09-26 |
| 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 | 2016-09-26 |
| 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 | 2016-09-26 |