MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-12-28 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[96128667]
(b)(4). The device involved in this complaint has not been received by the manufacturer at the time of this report. Customer complaint is confirmed by visual inspection of the photo submitted by the customer. On visual inspection test of said photo, part of the handle was observed on the bite block which indicates that it was bonded correctly. In order to perform a detailed analysis of the part to determine the root cause of the issue, it is necessary to have the device involved in this complaint. A conclusion code could not be chosen because although the complaint is confirmed by photo examination, the root cause is unknown at this time. Based on the picture it is not possible to determine that the event was caused by a manufacturing issue. If the device becomes available at a later date this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[96128668]
Customer complaint received via (b)(4). Report alleges "while waking up a patient from anesthesia, the bite block broke off in the patient's mouth. The end portion of the bite block was able to be removed by the anesthesia provider safely. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00478 |
| MDR Report Key | 7151321 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-12-28 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2017-12-28 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BITE-GARD MOLAR BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2017-12-28 |
| Returned To Mfg | 2017-12-27 |
| Catalog Number | 1140 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |