MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for BITEGARD manufactured by Hudson Rci / Teleflex Medical.
[175915268]
The bitegard was placed in the correct position once lma was secured at beginning of case. Upon emergence, the pt was awakened and the lma removed with no complications. The pt had the bitegard in his mouth but was not forcibly biting down. I attempted to remove the bitegard with minimal pressure and the white handle separated from the green bite piece. Thankfully i was able to grab the green piece with my hand and luckily the pt did not bite my finger in the process. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092334 |
| MDR Report Key | 9601527 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-14 |
| Date of Event | 2020-01-09 |
| Date Added to Maude | 2020-01-17 |
| 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 | RISK MANAGER |
| 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 | BITEGARD |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2020-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUDSON RCI / TELEFLEX MEDICAL |
| Manufacturer Address | MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-16 |