MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for BREATHE RIGHT NASAL STRIP manufactured by Glaxosmithkline Consumer Healthcare Holdings.
[97566657]
I have been using breathe right nasal strips for a long time. I have noticed increased itching. I ended up pulling nasal strip off during the night. On the box there is a statement about latex allergies. I have had several surgeries and have never had a problem with latex. I explained to the mfr that i am having a reaction to the adhesive and questioned what that is made of, not a very good explanation. They have received complaints about itching from other consumers as well. I have tried a few types of strips they made. Inconsistency with the strips either sticking to the point that layers of skin come off when removed, or the strip comes off before it should. Thank you. (b)(6). "mfr, what is the actual material in the product. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074579 |
| MDR Report Key | 7193978 |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-11 |
| Date of Event | 2010-01-01 |
| Date Added to Maude | 2018-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATHE RIGHT NASAL STRIP |
| Generic Name | DILATOR NASAL |
| Product Code | LWF |
| Date Received | 2018-01-12 |
| Lot Number | 5229XC1153525 |
| Device Expiration Date | 2020-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |