MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-05 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec Div Of Scarpa Healthcare.
[137865382]
Mdr: 2320643-2019-00001 is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10
[137865383]
The doctor said he may have skin cancer (skin cancer). He did that and he wound up with a sore on his nose (nasal soreness). It has torn the skin off his nose (application site skin tear). He wound up with a sore on his nose (application site injury). Case description: this case was reported by a consumer and described the occurrence of skin cancer in a (b)(6) year-old 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 skin cancer (serious criteria gsk medically significant), nasal soreness, application site skin tear and application site injury. The action taken with breathe right nasal strips was unknown. On an unknown date, the outcome of the skin cancer, nasal soreness, application site skin tear and application site injury were unknown. The reporter considered the skin cancer to be possibly related to breathe right nasal strips. The reporter considered the nasal soreness, application site skin tear and application site injury to be related to breathe right nasal strips. Additional information adverse event information was received on 25 february 2019, via phone call. Consumer reported that, "my brother told me not just to rip off the strips he did that and he wound up with a sore on his nose. He is having difficulty removing the sore, and he visited a doctor. It has torn the skin off his nose. The doctor said he may have skin cancer. This case was linked with (b)(4). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2019-00001 |
| MDR Report Key | 8391055 |
| Report Source | CONSUMER |
| Date Received | 2019-03-05 |
| Date of Report | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-05 |
| 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 |
| Manufacturer City | RESEARCH TRIANGLE PARK 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 | 2019-03-05 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| 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 | 2019-03-05 |