MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-11 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[97056712]
This report is associated with (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[97056713]
Bleeding due to breathe right extra. [hemorrhage] the regular ones didn't stick as well and itch. [application site itching] case description: this case was reported by a consumer and described the occurrence of hemorrhage in a male patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for difficulty breathing. This case was associated with a product complaint. Concomitant products included no therapy. On (b)(6) 2017, the patient started breathe right nasal strips. On an unknown date, an unknown time after starting breathe right nasal strips, the patient experienced hemorrhage (serious criteria gsk medically significant), application site itching and product complaint. On an unknown date, the outcome of the hemorrhage, application site itching and product complaint were unknown. The reporter considered the hemorrhage and application site itching to be related to breathe right nasal strips. Additional information: adverse event information was received on 01 january 2018. Consumer reported bleeding due to breathe right nasal strip. Follow up information was received on 02 january 2018. Consumer said, "the regular ones didn't stick as well and itch. I found the extra stay on better and didn't itch. " action taken for this was unknown. Initial and follow up information was added in above narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2018-00001 |
| MDR Report Key | 7183783 |
| Report Source | CONSUMER |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-01 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-01-11 |
| 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 | 2018-01-11 |
| Lot Number | UNK |
| 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. Other | 2018-01-11 |