MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-28 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.
[63427452]
This report is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[63427453]
Addicted to breathe right nasal strips. 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 nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. 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 addiction (serious criteria gsk medically significant and other: gsk medically significant ). Breathe right nasal strips was continued with no change. On an unknown date, the outcome of the addiction was unknown. The reporter considered the addiction to be related to breathe right nasal strips. Additional details, adverse event information was received on 19 december 2016. Consumer indicated that he was addicted to breathe right nasal strips (variant not specified).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2016-00014 |
| MDR Report Key | 6210518 |
| Report Source | CONSUMER |
| Date Received | 2016-12-28 |
| Date of Report | 2016-12-19 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2016-12-28 |
| 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 | 2016-12-28 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2016-12-28 |