MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for BREATHE RIGHT NASAL STRIPS EXTRA manufactured by Webtec Div Of Scarpa Healthcare.
[106383928]
Mdr 2320643-2018-00002 is associated with (b)(4), breathe right nasal strips extra.
Patient Sequence No: 1, Text Type: N, H10
[106383929]
Husband having choking [choking], husband having coughing [cough], husband having gaggng [gagging], husband having sleeplessness [sleeplessness], husband having swelling of face [facial swelling], husband having swelling of mouth [swollen mouth], husband having swelling of tongue [swollen tongue], husband having trouble breathing [difficulty breathing]. Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) male patient who received breathe right nasal strips (breathe right nasal strips extra) nasal strip (batch number 51788dxxf17, expiry date unknown) for snoring. On an unknown date, the patient started breathe right nasal strips extra at an unknown dose and frequency. On an unknown date, an unknown time after starting breathe right nasal strips extra, the patient experienced choking (serious criteria gsk medically significant), cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing. Breathe right nasal strips extra was discontinued (dechallenge was negative). On an unknown date, the outcome of the choking, cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the choking, cough, gagging, sleeplessness, facial swelling, swollen mouth, swollen tongue and difficulty breathing to be related to breathe right nasal strips extra. Additional details, adverse event information was received on 18 april 2018. The consumer called in about breathe right and asked if there was a side effect of swelling of face tongue and mouth. The consumer stated that her husband having trouble breathing, coughing, choking, gaging, sleeplessness, swelling of face, tongue and mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2018-00002 |
| MDR Report Key | 7456896 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-04-24 |
| 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,, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATHE RIGHT NASAL STRIPS EXTRA |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-04-24 |
| Lot Number | 51788DXXF17 |
| 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 | 2018-04-24 |