MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-18 for BITE GUARD 1140 manufactured by Hudson Rci.
[698712]
Inserted a bite guard [oral bite block] during an anesthetic. While waking the pt up, she bit on the guard snapping the device into 2 pieces. One piece came out of her mouth and the other was lodged between the posterior molar teeth. The small piece that remained in her mouth could have been easily aspirated into the lungs. Diagnosis or reason for use: prevent biting on artificial airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003815 |
| MDR Report Key | 917832 |
| Date Received | 2007-09-18 |
| Date of Report | 2007-09-18 |
| Date of Event | 2007-09-14 |
| Date Added to Maude | 2007-10-01 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE GUARD |
| Generic Name | NONE |
| Product Code | BRW |
| Date Received | 2007-09-18 |
| Model Number | 1140 |
| ID Number | 11079 07307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 892370 |
| Manufacturer | HUDSON RCI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2007-09-18 |