MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-30 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[61153288]
This report is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[61153289]
She also stated she had a stroke. She also stated she had a stroke and can not sleep. Consumer stated she needs a sleep mask, having trouble with her eyes. I'm needing a sleep mask. I have trouble with my eyes. Any kind of light bothers me/ sensitive to light. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for drug use for unknown indication. 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 stroke (serious criteria gsk medically significant, life threatening and other: gsk medically significant), difficulty sleeping, eye disorder and photophobia. The action taken with breathe right nasal strips was unknown. On an unknown date, the outcome of the stroke, difficulty sleeping, eye disorder and photophobia were unknown. It was unknown if the reporter considered the stroke, difficulty sleeping, eye disorder and photophobia to be related to breathe right nasal strips. Additional details, consumer reported that her dad used them he also died from cancer so thanks for helping him breath easy. She started using them after that just to try it in bad cold worked great now she was needing a sleep mask. She had stroke and had trouble eyes could not sleep any kind of light bothered her.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2016-00012 |
| MDR Report Key | 6136083 |
| Report Source | CONSUMER |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-27 |
| Date Mfgr Received | 2016-11-27 |
| Date Added to Maude | 2016-11-30 |
| 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 | 2016-11-30 |
| Lot Number | UNK |
| 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. Life Threatening; 2. Other | 2016-11-30 |