MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-29 for FLEXBLUE * manufactured by King Systems.
[1102837]
The bite block used to prevent the patient from biting on the endotracheal tube was found in the patient's laryngopharynx while the nurse was performing oral care after the patient had already been extubated. It appears to have slipped down into the back of the throat without staff being aware. The patient developed stridor that resolved after the device was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410833 |
| MDR Report Key | 1410833 |
| Date Received | 2009-06-29 |
| Date of Report | 2009-06-29 |
| Date of Event | 2009-06-03 |
| Report Date | 2009-06-29 |
| Date Reported to FDA | 2009-06-29 |
| Date Added to Maude | 2009-07-09 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | FLEXBLUE |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2009-06-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-29 |