MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-12-08 for BITE BLOCK 00712812 manufactured by United States Endoscopy Group, Inc..
[94242059]
The product was not returned to us endoscopy and the lot number is unknown. The instructions for use include the following: "assess the patient's oral capacity to ensure it is compatible with the size requirements of the bite block. Assess patient for appropriate or intact dentition as well as oral and maxillofacial trauma prior to using and after removal of the bite block. Place the bite block in the patient's mouth. If the retaining strap is used, secure the strap on the bite block. To secure retaining strap (if applicable): insert the retaining strap through posterior aspect of side port and thread over cleat. " in-service training on use of the adjustable woven strap has been provided to the user. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[94242060]
The bite block with retaining strap is used to protect the endoscope insertion tube from being bitten by the patient. The product includes an adjustable woven retaining strap which is used to secure the bite block to the patient's mouth. The user facility reported abrasion to patient's lips following procedures which included use of the bite block. The patients were treated with a topical ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2017-00038 |
| MDR Report Key | 7099740 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-08 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-12-08 |
| 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 | 3 |
| Brand Name | BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2017-12-08 |
| Model Number | 00712812 |
| Catalog Number | 00712812 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-12-08 |