MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for INTRANASAL MUCOSAL ATOMIZATION DEVICE manufactured by Teleflex Medical.
[72543268]
Patient Sequence No: 1, Text Type: N, H10
[72543269]
Safety concern regarding product recall and there is no other option for use. In this particular patient's case, failure of the device led to patient experiencing seizure. Nasal atomized verse was not able to be provided due to unavailability of nasal atomizer. No non-recalled atomizer could be located and patient's seizure resolved on its own without pharmaceutical intervention that would have likely shortened the duration. Manufacturer response for nasal atomizer, lma mad nasal intranasal mucosal atomization device (per site reporter): no replacement options have been identified or provided to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6485214 |
| MDR Report Key | 6485214 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-01-03 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-04-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRANASAL MUCOSAL ATOMIZATION DEVICE |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
| Product Code | CCQ |
| Date Received | 2017-04-12 |
| ID Number | MAD130OS, MAD140, MAD140OS, M |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BOULEVARD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |