MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-04-25 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.
[106704350]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the defect was not provided at the time of this report. 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. A root cause is unknown. To perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish any corresponding corrective actions, it is necessary to evaluate the sample involved in this complaint. If the sample becomes available this report will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[106704451]
Customer complaint alleges "on this occasion the nurse was cleaning the patient's teeth, brushing around the block and holding the bite block handle when it the handle snapped off from the body of the block. " medical intervention reported was retrieval of bite block with forceps. There was no injury or complication reported related to the alleged device event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2018-00144 |
| MDR Report Key | 7462446 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-05-14 |
| Date Added to Maude | 2018-04-25 |
| 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 ORAL BITE BLOCK,INTL |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2018-04-25 |
| Returned To Mfg | 2018-04-27 |
| Catalog Number | 41140 |
| 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 | 1. Required No Informationntervention | 2018-04-25 |