MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2011-09-08 for HUDSON BITE-GARD ORAL BITE BLOCK,INTL 41140 manufactured by Teleflex Medical.
[21408609]
The event is reported as: complaint alleges that while using the biteguard; the patient bit the end of the biteguard and the piece became lodged in the patient's trachea. The patient had to go to theatres (operating room) to have the piece removed. Patient current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
[21535278]
The device sample was not received by the manufacturer at the time of this report. A follow-up report will be sent when completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2011-00373 |
| MDR Report Key | 2268170 |
| Report Source | 01,06,07 |
| Date Received | 2011-09-08 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-30 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-05-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | AVE. TRANSFORMACION 5954 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 | BITE-GARD |
| Product Code | JXL |
| Date Received | 2011-09-08 |
| Catalog Number | 41140 |
| Lot Number | 02K1000616 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-08 |