MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-07 for EZ-SPRAY ATOMIZER EZ-103A manufactured by Alcove Medical Inc..
[79949138]
Patient Sequence No: 1, Text Type: N, H10
[79949139]
Physician was tropicalizing patient's oropharynx for awake intubation when the nozzle of the ez-spray device broke off into patient's mouth. The patient was able to stop the parts with his tongue and spit the components out. The components were a spring and push rod. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6692311 |
| MDR Report Key | 6692311 |
| Date Received | 2017-07-07 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-06-14 |
| Report Date | 2017-06-29 |
| Date Reported to FDA | 2017-06-29 |
| Date Reported to Mfgr | 2017-06-29 |
| Date Added to Maude | 2017-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | EZ-SPRAY ATOMIZER |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
| Product Code | CCQ |
| Date Received | 2017-07-07 |
| Model Number | EZ-103A |
| Catalog Number | EZ-103A |
| Lot Number | NO LOT IDENTIFIED |
| ID Number | A9999 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCOVE MEDICAL INC. |
| Manufacturer Address | 3905 E BARTON CREEK DR EAGLE MOUNTAIN 84005 US 84005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-07 |