MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-26 for BITE BLOCK - MAXI 00712804 manufactured by United States Endoscopy Group, Inc..
[4796209]
Us endoscopy received fda notification that an mdr which had been filed by a clinical user (uf/importer report # 4506770000-2014-8002). The user reported damage to patient dentition during use of bite block - maxi (00712804). The mdr event description includes: 'we are investigating and trailing a new bite block with a foam element due to three occurrences of dental damage with us endoscopy maxi bite block over the past 12 months. One was the dental crown and part of the tooth was spat out after the transesophageal echocardiogram (tee) and cardioversion once the patient woke up. The other two were during removal of the bite block after esophagogastroduodenoscopy (egd) procedures. What was the original intended procedure: scope and dental protection during tee/cardioversions and egd. ' the mdr additional information includes: 'the patient was (b)(6) year old female with previous dental crown on this particular patient but have had two other occurrences. '
Patient Sequence No: 1, Text Type: D, B5
[12242754]
The bite block - maxi is a single piece circular plastic bite block with oval hole (60 fr) in the center for insertion of the endoscope, and includes retention strap. The bite block is used to protect the endoscope insertion tube from being bitten by the patient. Warnings and precautions found in the instructions for use include: when placing the bite block in the patient's mouth, care should be exercised to avoid placing fingers between the bite block and the patient's teeth. Flexible endoscopy procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques. Consult the medical literature relative to techniques, complications and hazards prior to the performance of an endoscopic procedure. The device lot number was not identified and the device was not returned for examination. The clinical user report does not indicate a malfunction of the device (such as cracking or collapse) which could contribute to dental damage. This report will be updated if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1528319-2014-00018 |
| MDR Report Key | 4137580 |
| Report Source | 05 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date Mfgr Received | 2014-08-29 |
| Date Added to Maude | 2014-10-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL OLEKSA |
| Manufacturer Street | 5976 HEISLEY RD. |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586263 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE BLOCK - MAXI |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2014-09-26 |
| Model Number | 00712804 |
| Catalog Number | 00712804 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| 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. Other | 2014-09-26 |