MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for BITE BLOCK - MAXI - VELCRO STRAP 00712806 manufactured by United States Endoscopy Group, Inc..
[98169297]
This report is made in response to a medwatch ((b)(4)). The report was investigated and confirmed there was no harm to the patient or user.
Patient Sequence No: 1, Text Type: N, H10
[98169298]
The user facility reported bite block was missing from two pouches. There was no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00003 |
| MDR Report Key | 7207723 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-03-08 |
| Date of Event | 2017-12-04 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2017-10-21 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586251 |
| Manufacturer G1 | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BITE BLOCK - MAXI - VELCRO STRAP |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2018-01-19 |
| Model Number | 00712806 |
| Catalog Number | 00712806 |
| Lot Number | 1717366 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |