MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for BITE GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[94666667]
Patient Sequence No: 1, Text Type: N, H10
[94666668]
While waking up a patient from anesthesia, the bite block broke off in the patient's mouth. The end portion of the bite block was able to be removed by the anesthesia provider safely. This would have been an aspiration risk if the broken piece was not discovered and promptly removed. The pieces of the bite block were saved and images will be attached to this report. Per site reporter: awaiting manufacturer response. This device will be returned to the manufacturer for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7112203 |
| MDR Report Key | 7112203 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-22 |
| Report Date | 2017-12-06 |
| Date Reported to FDA | 2017-12-06 |
| Date Reported to Mfgr | 2017-12-06 |
| Date Added to Maude | 2017-12-13 |
| 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 | 3 |
| 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 | 3 |
| Brand Name | BITE GARD MOLAR BITE BLOCK |
| Generic Name | AIRWAY, ORAL, BITE BLOCK |
| Product Code | JXL |
| Date Received | 2017-12-13 |
| Catalog Number | 1140 |
| Lot Number | N/A |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BOULEVARD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |