MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-21 for BREATHE RIGHT NASAL STRIPS TAN manufactured by Webtec A Division Of Scarpa Healthcare.
[83126465]
This report is associated with argus (b)(4), breathe right nasal strips tan.
Patient Sequence No: 1, Text Type: N, H10
[83126466]
Before my husband died, he used the breathe right nasal strips tan large [unknown cause of death]. Case description: this case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received breathe right nasal strips (breathe right nasal strips tan) nasal strip (batch number unk, expiry date unknown) for product used for unknown indication. Concomitant products included no therapy. On an unknown date, the patient started breathe right nasal strips tan. On an unknown date, an unknown time after starting breathe right nasal strips tan, the patient experienced unknown cause of death (serious criteria death and gsk medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to breathe right nasal strips tan. Additional details, adverse event information was received on 14 august 2017. The reporter stated, "before my husband died, he used the breathe right nasal strips tan large (count not specified)". Lot number and expiration date were unknown. This is 2 of the 2 reports from the same reporter. This case is linked to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320643-2017-00008 |
| MDR Report Key | 6807023 |
| Report Source | CONSUMER |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-14 |
| Date Mfgr Received | 2017-08-14 |
| Date Added to Maude | 2017-08-21 |
| 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 NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHE RIGHT NASAL STRIPS TAN |
| Generic Name | NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2017-08-21 |
| 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 A DIVISION OF SCARPA HEALTHCARE |
| Manufacturer Address | 5900 MIDDLE VIEW WAY KNOXVILLE TN 37909 US 37909 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-08-21 |