MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for EQUATE NASAL STRIPS manufactured by Equate / Perrigo Company.
[112843561]
Used equate nasal strip on (b)(6) 2018, upon removal on (b)(6) 2018 just when i got to the end on the left, it felt like a sting. Looked in the mirror and my skin had come off on the left. Bought at (b)(6). Frequency: once at bedtime, on the skin. Dates of use: (b)(6) 2018 - (b)(6) 2018. To stop snoring, keep nasal passage open. The problem stopped after the person reduced the dose or stopped taking or using the product, after two weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078106 |
| MDR Report Key | 7645320 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-20 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | EQUATE NASAL STRIPS |
| Generic Name | DILATOR NASAL |
| Product Code | LWF |
| Date Received | 2018-06-27 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EQUATE / PERRIGO COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2018-06-27 |