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 2017-11-21 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[93452030]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report. The device history record was reviewed and no issues or discrepancies were found which could potentially relate to this complaint. Customer complaint cannot be confirmed based only on the information provided. In order to perform a proper and thorough investigation to confirm the complaint and determine the source of alleged defect reported it is necessary to evaluate the sample involved in this complaint. If the device sample becomes available at a later date this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[93452151]
Customer complaint alleges "the white plastic handle on the bite guard broke when being removed from a patient. " customer reported there was not injury or consequence to the patient. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00413 |
| MDR Report Key | 7049743 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2017-11-21 |
| 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 | 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 MOLAR BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2017-11-21 |
| Catalog Number | 1140 |
| Lot Number | 74G1701128 |
| Device Availability | N |
| 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 | 2017-11-21 |