MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for BREATHE RIGHT STRIPS manufactured by Glaxosmithkline Consumer Healthcare Lp.
[115792934]
I used breathe right strips on the external part of my nose to prevent snoring and i got a nasty infection on my nose. I had to go to the dr a few times to get antibiotics. In contacted the mfr but they didn't do anything. The dr took a sample of the infection and sent it to the lab for testing. I don't think anything really bad was discovered since i wasn't notified of any problem. Dates of use: (b)(6) 2018. Reason for use: to stop snoring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078718 |
| MDR Report Key | 7738848 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-01-22 |
| Date Added to Maude | 2018-08-01 |
| 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 STRIPS |
| Generic Name | BREATHE RIGHT STRIPS |
| Product Code | LWF |
| Date Received | 2018-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE LP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |