MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-14 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[36347717]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned. No photo available. The device history record review shows that the product was assembled and inspected according to our specifications. No issues or discrepancies were found which could potentially relate to this complaint. Customer complaint cannot be confirmed due to the lack of sample. If the device sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[36347718]
The customer alleges that a piece of the device broke off into a patient's mouth while performing electric shock treatment. The broken piece was retrieved and the patient was fine. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00077 |
| MDR Report Key | 5367419 |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-06-20 |
| Date Mfgr Received | 2016-01-06 |
| Device Manufacturer Date | 2015-03-16 |
| Date Added to Maude | 2016-01-14 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 | 0 |
| Brand Name | HUDSON BITE-GARD MOLAR BITE BLOCK |
| Generic Name | ENDO. BITE GARD AND ACCESSOR. |
| Product Code | MNK |
| Date Received | 2016-01-14 |
| Catalog Number | 1140 |
| Lot Number | 74C1502345 |
| 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 | 2016-01-14 |