MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-15 for BREATHE RIGHT NASAL STRIPS EXTRA manufactured by Webtec A Division Of Scarpa Healthcare.
[70061495]
Medwatch 2320643-2017-00002 is associated with argus case (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[70061496]
Chronic sinus problems that had required surgery [sinus disorder]. Case description: this case was reported by a consumer and described the occurrence of sinus disorder in a male patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 491980xxj16, expiry date unknown) for difficulty breathing. This case was associated with a product complaint. Concomitant products included no therapy. In 2008, the patient started breathe right nasal strips extra. On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced sinus disorder (serious criteria clinically significant/intervention required) and product complaint. On an unknown date, the outcome of the sinus disorder and product complaint were unknown. It was unknown if the reporter considered the sinus disorder to be related to breathe right nasal strips extra. This report is made by (b)(4) without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, adverse event information was received by email on 09 march 2017. The consumer said she had used breath right products (right nasal strips extra) for about nine years (2008). She has had chronic sinus problems that had required surgery three times in those years, most recently last week ((b)(6) 2017). She stated that she found that the product was the only safe thing to use to breath. The last four boxes she had issues with the adhesive not working at one end of the strip. This present box had a fifty percent failure of product. That was not an exaggeration. The lot number was 491980xxj16 on the box.
Patient Sequence No: 1, Text Type: D, B5
[70573371]
Mfr 2320643-2017-00002 is associated with argus case (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[70573372]
Case description: this case was reported by a consumer and described the occurrence of sinus disorder in a male patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 491980xxj16, expiry date unknown) for difficulty breathing. This case was associated with a product complaint. Concomitant products included no therapy. In 2008, the patient started breathe right nasal strips extra. On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced sinus disorder (serious criteria clinically significant/intervention required) and product complaint. On an unknown date, the outcome of the sinus disorder and product complaint were unknown. It was unknown if the reporter considered the sinus disorder to be related to breathe right nasal strips extra. Additional details, adverse event information was received by email on 09 march 2017. The consumer said she had used breath right products (right nasal strips extra) for about nine years (2008). She has had chronic sinus problems that had required surgery three times in those years, most recently last week ((b)(6) 2017). She stated that she found that the product was the only safe thing to use to breath. The last four boxes she had issues with the adhesive not working at one end of the strip. This present box had a fifty percent failure of product. That was not an exaggeration. The lot number was 491980xxj16 on the box. Follow up information was received on 16 march 2017. The reporter's contact details were updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00002 |
| MDR Report Key | 6407989 |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-09 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-03-15 |
| 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 EXTRA |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-03-15 |
| Lot Number | 491980XXJ16 |
| 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. Required No Informationntervention | 2017-03-15 |