MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-12 for * CND000429 manufactured by Conmed Corporation.
[5131685]
Patient was undergoing egd for findings of esophageal stricture and dysphagia. Bite block caused irritation on both sides of his mouth during the procedure causing bleeding. Area irrigated very carefully. The patient tolerated the procedure well and was sent to recovery in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4316116 |
| MDR Report Key | 4316116 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-11-12 |
| Date of Event | 2014-09-03 |
| Report Date | 2014-11-12 |
| Date Reported to FDA | 2014-11-12 |
| Date Reported to Mfgr | 2014-12-10 |
| Date Added to Maude | 2014-12-10 |
| 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 |
| 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 | * |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2014-11-12 |
| Model Number | * |
| Catalog Number | CND000429 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-12 |