MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for LASER-SHIELD II ENDOTRACHEAL TUBE manufactured by Medtronic Xomed.
[25891925]
On (b)(6) 2015, patient underwent transoral sialolithotomy during this procedure she was intubated nasally with a laser protected endotracheal tube. On (b)(6) 2015, surgeon documented that patient had developed a right nasal synechiae as a result of the nasal intubation with the laser protected tube. The synechiae had to be surgically divided in the clinic setting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056134 |
| MDR Report Key | 5077543 |
| Date Received | 2015-09-10 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-09-03 |
| Date Added to Maude | 2015-09-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | LASER-SHIELD II ENDOTRACHEAL TUBE |
| Generic Name | LASER-SHIELD II ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2015-09-10 |
| ID Number | 7060400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-10 |