MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-31 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[58767682]
This report is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[58767683]
Edge of the strip had come unfastened, so he removed it, and with that, layers of his skin [application site desquamation]. Now has a significant scab [application site scab]. Now has a significant scab, opening up each day upon showering [application site reaction]. Case description: this case was reported by a consumer and described the occurrence of application site desquamation in a male patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. This case was associated with a product complaint. 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 application site desquamation (serious criteria other: serious as per reporter), application site scab (serious criteria other: serious as per reporter), application site reaction (serious criteria other: serious as per reporter) and product complaint. On an unknown date, the outcome of the application site desquamation, application site scab and application site reaction were not recovered/not resolved and the outcome of the product complaint was unknown. The reporter considered the application site desquamation to be related to breathe right nasal strips. It was unknown if the reporter considered the application site scab and application site reaction to be related to breathe right nasal strips. Additional details, the adverse event information received via email on 25 october 2016. Consumer reported the issue was a very serious issue. Consumer said her husband had been using breathe right nasal strips variant not specified successfully. The other night her husband cleansed and washed his face, applied the breathe right strip and went to bed. Upon waking in the middle of the night, the edge of the strip had come unfastened, so he removed it, and with that, layers of his skin. They always buy the sensitive skin ones and this particular one was from the same box he had used prior to this incident. She said something in the quality of this strip went terribly wrong. She said he now had a significant scab, opening up each day upon showering. The adverse event revision was received on 27 october 2016. Event of wound at application site had been added to this case since the consumer stated her husband now had a significant scab, opening up each day upon showering. The initial and revision information was included in above narrative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2016-00011 |
| MDR Report Key | 6066715 |
| Report Source | CONSUMER |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-25 |
| Date Mfgr Received | 2016-10-25 |
| Date Added to Maude | 2016-10-31 |
| 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 |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2016-10-31 |
| 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 | 2016-10-31 |