MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for VITAL SIGNS? ORAL AIRWAY 3590 manufactured by Vyaire Medical.
[139569491]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139569492]
It was reported to vyaire via a medwatch report that upon extubation, an oral airway was placed, simultaneously, the clinician noted a loose piece of plastic at the top of the airway. When the clinician attempted remove the loose piece of plastic, the patient inhaled and sucked the piece of plastic to the back of her throat. The clinician was able to remove the piece of plastic to prevent aspiration. The customer confirmed that there was no patient injury associated with the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2019-00031 |
| MDR Report Key | 8398940 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-01-24 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-03-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V # 85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITAL SIGNS? ORAL AIRWAY |
| Generic Name | AIRWAY ACCESS |
| Product Code | BZA |
| Date Received | 2019-03-07 |
| Catalog Number | 3590 |
| Lot Number | 0001199122 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-07 |