MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-08 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[69369430]
Report # 2320643-2017-00001 is associated with (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[69369431]
Nose is raw/ have been treating it for 5 days. Still raw [nasal passage irritation] last one i took off brought skin n all off. It really looks serious [application site desquamation]. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of nasal passage irritation in a female patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. Concomitant products included no therapy. 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 nasal passage irritation (serious criteria other: as per reporter) and application site desquamation (serious criteria other: as per reporter). The action taken with breathe right nasal strips was unknown (dechallenge was negative). On an unknown date, the outcome of the nasal passage irritation was not recovered/not resolved and the outcome of the application site desquamation was unknown. It was unknown if the reporter considered the nasal passage irritation and application site desquamation to be related to breathe right nasal strips. Additional details: adverse event information was received on 23 february 2017. Consumer reported breathe right variant not specified. The consumer reported that "i like them to but my nose is raw. The last one i took off brought skin and all off. It really looks serious. I have been treating it for 5 days. Still raw". Lot and expiration date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[75237841]
Nose is raw/ have been treating it for 5 days. Still raw [application site irritation] last one i took off brought skin n all off. It really looks serious [application site desquamation]. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of nasal passage irritation in a female patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. Concomitant products included no therapy. 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 nasal passage irritation (serious criteria other: as per reporter) and application site desquamation (serious criteria other: as per reporter). The action taken with breathe right nasal strips was unknown (dechallenge was negative). On an unknown date, the outcome of the nasal passage irritation was not recovered/not resolved and the outcome of the application site desquamation was unknown. It was unknown if the reporter considered the nasal passage irritation and application site desquamation to be related to breathe right nasal strips. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details, adverse event information was received on 23 february 2017. Consumer reported breathe right variant not specified. The consumer reported that "i like them to but my nose is raw. The last one i took off brought skin and all off. It really looks serious. I have been treating it for 5 days. Still raw". Lot and expiration date was not provided. This report is being resubmitted to capture corrections for initial version dated on 23 february 2017. The event of nasal passage irritation was changed to application site irritation. On an unknown date, the outcome of the application site irritation was not recovered/not resolved. It was unknown if the reporter considered the application site irritation to be related to breathe right nasal strips. No more corrections were made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00001 |
| MDR Report Key | 6387520 |
| Report Source | CONSUMER |
| Date Received | 2017-03-08 |
| Date of Report | 2017-02-23 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-08 |
| 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 | 2017-03-08 |
| 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 | 2017-03-08 |