MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-05-10 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec Div Of Scarpa Healthcare.
[144689120]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144689121]
Hypersensitivity [hypersensitivity]. Itching of skin on nose [application site itching]. Case description: this case was reported by a other health professional via regulatory authority and described the occurrence of hypersensitivity in a (b)(6) male patient who received breathe right nasal strips nasal strip for nasal congestion and cold. 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 hypersensitivity (serious criteria other: serious harm) and application site itching. The action taken with breathe right nasal strips was unknown. On an unknown date, the outcome of the hypersensitivity and application site itching were unknown. It was unknown if the reporter considered the hypersensitivity and application site itching to be related to breathe right nasal strips. Additional details: patient was used product before bedtime but on the next day discovered itching on the skin of his nose. He had allergic reaction of the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2019-00002 |
| MDR Report Key | 8599336 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-11 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-10 |
| 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 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 NASAL STRIPS |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2019-05-10 |
| 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 DIV OF SCARPA HEALTHCARE |
| Manufacturer Address | KNOXVILLE TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-10 |