MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-20 for BITE BLOCK - MAXI * manufactured by Us Endoscopy.
[1431513]
Patient undergoing an esophagogastroduodenoscopy (egd). During the procedrue a bite block was placed. When patient woke up in recovery it was noted that she had a 1mm cut on the inside right side of her lip. Bite block inspected. No sharp edges noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1845177 |
| MDR Report Key | 1845177 |
| Date Received | 2010-09-20 |
| Date of Report | 2010-07-06 |
| Date of Event | 2010-05-25 |
| Report Date | 2010-07-06 |
| Date Reported to FDA | 2010-09-20 |
| Date Added to Maude | 2010-09-27 |
| 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 |
| 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 | BITE BLOCK - MAXI |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2010-09-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US ENDOSCOPY |
| Manufacturer Address | 5976 HEISLEY RD. MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-20 |