MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-13 for AMBU AURASTRAIGHT SILICONE 342300000, 342500000, 342400000 manufactured by Besmed Health Business Corporation.
[166180932]
Anesthesiologist attempted to place laryngeal mask airway (lma) x3 (ambu aurastraight silicone single use laryngeal mask) with difficulty and without success. Lma of various sizes would not go down or stay in the proper place. Patient had moderate bloody secretions. Anesthesia's plan for general anesthesia converted to monitored anesthesia care. Mac sedation used for procedure instead of planned general anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9314545 |
| MDR Report Key | 9314545 |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-09-27 |
| Report Date | 2019-11-05 |
| Date Reported to FDA | 2019-11-05 |
| Date Reported to Mfgr | 2019-11-13 |
| Date Added to Maude | 2019-11-13 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | AMBU AURASTRAIGHT SILICONE |
| Generic Name | AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY |
| Product Code | CAE |
| Date Received | 2019-11-13 |
| Model Number | 342300000, 342500000, 342400000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BESMED HEALTH BUSINESS CORPORATION |
| Manufacturer Address | 13729 SHADOW RIDGE CHINO HILLS CA 91709 US 91709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-13 |