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 |