MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-22 for ESOPHAGEAL/RECTAL TEMPERATURE PROBE * ES400-18 manufactured by Smiths Medical Asd, Inc..
[20843236]
User alleges they were using the device during a cervical spine surgery with a posterior approach with the pt in mayfield tongs using electrocautery surgery. The pt received 3rd degree burns on his palate. The active electrode was used on the "back of the neck" and the ground electrode was a few inches lower on the posterior of the pt. The pt was under general anesthesia and was intubated with a traditional et tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221261-2008-00019 |
| MDR Report Key | 1055424 |
| Date Received | 2008-05-22 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-24 |
| Date Facility Aware | 2008-04-24 |
| Date Added to Maude | 2008-06-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL/RECTAL TEMPERATURE PROBE |
| Generic Name | 73BZT ESOPHAGEAL |
| Product Code | BZT |
| Date Received | 2008-05-22 |
| Model Number | * |
| Catalog Number | ES400-18 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1023333 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 160 WEYMOUTH ST ROCKLAND MA 02370 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-22 |