MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-29 for BREATHE RIGHT NASAL STRIPS EXTRA CLEAR manufactured by Webtec A Division Of Scarpa Healthcare.
[87853030]
This report is associated with (b)(4), breathe right nasal strips extra clear.
Patient Sequence No: 1, Text Type: N, H10
[87853031]
I tolerate the clear well. I am addicted to them (breathe right nasal strips extra clear) [addiction] case description: this case was reported by a consumer and described the occurrence of addiction in a male patient who received breathe right nasal strips (breathe right nasal strips extra clear) nasal strip (batch number unk, expiry date unknown) for difficulty breathing. Co-suspect products included breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number unk, expiry date unknown) for difficulty breathing. Concurrent medical conditions included hyperesthesia. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips extra clear and breathe right nasal strips tan. On an unknown date, an unknown time after starting breathe right nasal strips extra clear and breathe right nasal strips tan, the patient experienced addiction (serious criteria gsk medically significant), application site reaction, application site redness and application site irritation. Breathe right nasal strips extra clear was discontinued (dechallenge was negative). Breathe right nasal strips tan was discontinued (dechallenge was negative). On an unknown date, the outcome of the addiction, application site reaction, application site redness and application site irritation were not recovered/not resolved. The reporter considered the addiction to be related to breathe right nasal strips extra clear. The reporter considered the application site reaction, application site redness and application site irritation to be related to breathe right nasal strips tan. 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 27 september 2017. Consumer reported that "breathe right, clear, l, 30 ct. I use them every night. Three stores do not have it anymore. They do not have shelf space for it any longer. The tan ones irritates my sensitive nose. It makes more indentations and i wake up to a red nose. I tolerate the clear well. I am addicted to them".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00009 |
| MDR Report Key | 6905307 |
| Report Source | CONSUMER |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-27 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-09-29 |
| 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 EXTRA CLEAR |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-09-29 |
| Lot Number | UNK |
| 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 | 2017-09-29 |