MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-16 for BREATHE RIGHT (UNKNOWN) manufactured by Webtec Div Of Scarpa Healthcare.
[189040504]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[189040505]
Multiple broken noses [broken nose]. This case was reported by a consumer via call center representative and described the occurrence of broken nose in a patient who received breathe right nasal strips (breathe right (unknown)) nasal strip for product used for unknown indication. Concurrent medical conditions included septoplasty (botched). On an unknown date, the patient started breathe right (unknown). On an unknown date, an unknown time after starting breathe right (unknown), the patient experienced broken nose (serious criteria gsk medically significant). The action taken with breathe right (unknown) was unknown. On an unknown date, the outcome of the broken nose was unknown. It was unknown if the reporter considered the broken nose to be related to breathe right (unknown). This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. It was reported that patient had multiple broken nose and botched septoplasty. Patient had some funny looks but had to wear them to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2020-00001 |
| MDR Report Key | 9599351 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK, |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT (UNKNOWN) |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2020-01-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEBTEC DIV OF SCARPA HEALTHCARE |
| Manufacturer Address | KNOXVILLE, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-16 |