MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-16 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.
[114051590]
(b)(4). Visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report. Trend analysis for this device and device family, for the period (b)(6) 2017 to (b)(6) 2018, found four complaints were received for the same issue. A device history record review could not be conducted since the lot number was not provided. Customer complaint cannot be confirmed based only on the information provided. To perform a proper and thorough investigation, it is necessary to evaluate the sample involved in this complaint. If the device sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[114051591]
Customer complaint alleges "after a few hours of use, the patient bit hard which resulted in the white handle becoming separated from the green molar guard. " patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00219 |
| MDR Report Key | 7690227 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-03 |
| Date Added to Maude | 2018-07-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| 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 ORAL BITE BLOCK,INTL |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2018-07-16 |
| Catalog Number | 41140 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-16 |