MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for 710103 E-Z-GUARD ADULT MOUTHPIECE WITH FOAM AND VELCRO STRAP manufactured by United States Endoscopy Group, Inc..
[101573452]
The product consists of a mouthpiece and a velcro retaining strap. The device was not returned by the user facility for evaluation. The lot history record was reviewed and confirmed the device was manufactured to specification. The lot was manufactured in october 2017. No other complaints of any type are associated with this lot, nor have there been similar complaints on any other lots of this product. Statements from the instructions for use include: prior to clinical use, inspect and familiarize yourself with the device. If there is evidence of damage, do not use this product and contact your local product specialist. 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. If strap is velcro, press strips together to fasten and pull apart to unfasten. Us endoscopy sales representative discussed the event with the user facility, and observed proper use of the device following the event.
Patient Sequence No: 1, Text Type: N, H10
[101573453]
User facility reported that a piece of velcro was found in the patient's mouth. The piece was retrieved. There was no report of patient or user harm due to the detachment nor retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00005 |
| MDR Report Key | 7307897 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date Mfgr Received | 2018-02-02 |
| Device Manufacturer Date | 2017-10-19 |
| Date Added to Maude | 2018-03-01 |
| 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 | 710103 E-Z-GUARD ADULT MOUTHPIECE WITH FOAM AND VELCRO STRAP |
| Generic Name | BITE BLOCK |
| Product Code | MNK |
| Date Received | 2018-03-01 |
| Model Number | 710103 |
| Catalog Number | 710103 |
| Lot Number | 1716851 |
| 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 | 2018-03-01 |