MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-05-26 for HUDSON BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[45998463]
(b)(4). A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned. No photo available. The device history record of batch number 74a1600827 that belong to catalog number 1140 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled & inspected according to our specifications. Customer complaint cannot be confirmed due to the lack of a sample. An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time. If the device sample becomes available this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[45998464]
The customer alleges that a patient had a seizure and bit though the bite block. The patient broke the bite block, but the intubation tube blocked it from going any further. Forceps were used to remove the bite block. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2016-00223 |
| MDR Report Key | 5681883 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-03-19 |
| Date Mfgr Received | 2016-05-19 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2016-05-26 |
| 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 | 3 |
| Brand Name | HUDSON BITE-GARD MOLAR BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE GARD W/ ACCES. |
| Product Code | MNK |
| Date Received | 2016-05-26 |
| Catalog Number | 1140 |
| Lot Number | 74A1600827 |
| 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 | 2016-05-26 |