MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-08 for BREATHE RIGHT NASAL STRIPS EXTRA CLEAR manufactured by Webtec Div Of Scarpa Healthcare.
[144407124]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144407125]
He started choking [choking]. It turns out he had eaten 17 strips [accidental device ingestion by a child]. Case description: this case was reported by a consumer and described the occurrence of choking in a child male patient who received breathe right nasal strips (breathe right nasal strips extra clear) 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 extra clear at an unknown dose and frequency. On an unknown date, an unknown time after starting breathe right nasal strips extra clear, the patient experienced choking (serious criteria gsk medically significant) and accidental device ingestion by a child (serious criteria gsk medically significant). On an unknown date, the outcome of the choking and accidental device ingestion by a child were unknown. The reporter considered the choking to be related to breathe right nasal strips extra clear. It was unknown if the reporter considered the accidental device ingestion by a child to be related to breathe right nasal strips extra clear. Additional details, adverse event information was received via power review on (b)(6) 2019. Consumer reported that "last week, i left out a box of these strips and somehow my child got a hold of them. He started choking, so we ran him to the hospital. It turns out he had eaten 17 strips and needed to get his stomach pumped. Besides, product does not work whatsoever. I snore just as much as before, and it tore off an entire layer of skin off of my nose. My doctor said that the scar it left will be permanent. I will definitely be suing for damages". This case was linked with case (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2019-00003 |
| MDR Report Key | 8590672 |
| Report Source | CONSUMER |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-23 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 NASAL STRIPS EXTRA CLEAR |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2019-05-08 |
| 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 DIV OF SCARPA HEALTHCARE |
| Manufacturer Address | KNOXVILLE TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-08 |