MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for BITE BLOCK 00712806 manufactured by United States Endoscopy Group, Inc..
[96829821]
Patient Sequence No: 1, Text Type: N, H10
[96829822]
Package for bite block had no bite block in 2 packages from same lot #. Manufacturer response for bite block, bite block - maxi-velcro strap (per site reporter). Equipment failure reported to customer service representative. Arrangements made to return defective product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7177942 |
| MDR Report Key | 7177942 |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-12-04 |
| Report Date | 2017-12-28 |
| Date Reported to FDA | 2017-12-28 |
| Date Reported to Mfgr | 2017-12-28 |
| Date Added to Maude | 2018-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2018-01-10 |
| Catalog Number | 00712806 |
| Lot Number | 1717366 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY ROAD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |