MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-10-20 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[16374574]
The event was reported as: health care provider was attending to routine mouth care when it was noticed that the pt's bite-gard was no longer sitting in the right place. In an attempt to reposition it, the handle disconnected from the green plastic end. No pt injury reported. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[16651388]
Sample requested but not received yet. Evaluation report not available at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00057 |
| MDR Report Key | 1204669 |
| Report Source | 08 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-10-03 |
| Date Mfgr Received | 2008-10-03 |
| Date Added to Maude | 2009-11-18 |
| 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 | ANGELA BROWN, MGR, RA |
| Manufacturer Street | 4024 STIRRUP CREEK DR |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE-GARD MOLAR BITE BLOCK |
| Generic Name | BITE GARD |
| Product Code | JXL |
| Date Received | 2008-10-20 |
| Catalog Number | 1140 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-20 |