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 2010-08-26 for HUDSON BITE-GARD 1140 manufactured by Teleflex Medical.
[1710085]
The event is reported as: the green piece of the bite-gard separated from the white piece. The device was being removed from the pt's mouth when the incident occurred. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8788173]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2010-00217 |
| MDR Report Key | 1829200 |
| Report Source | 01,06,07 |
| Date Received | 2010-08-26 |
| Date of Report | 2010-08-17 |
| Date Mfgr Received | 2010-08-17 |
| Date Added to Maude | 2010-12-28 |
| 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 | MICHAEL TAGGART, VP |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334916 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BITE-GARD |
| Generic Name | MOLAR BITE BLOCK |
| Product Code | JXL |
| Date Received | 2010-08-26 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | 00766 |
| ID Number | NA |
| 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 | 2010-08-26 |