MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-29 for BITE-GARD MOLAR BITE BLOCK 1140 manufactured by Teleflex Medical.
[16169479]
The event was reported that following an operation, the patient was being reversed from the anesthetic. It was alleged that in the attempt to remove the bite guard, the bite guard snapped and the green prop part fell back into the patient's pharynx. The part was retrieved but caused concern for the anesthetist. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[16238056]
Sample sent to manufacturing facility for evaluation. Evaluation report not available at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00044 |
| MDR Report Key | 1180987 |
| Report Source | 07 |
| Date Received | 2008-09-29 |
| Date of Report | 2008-09-02 |
| Date Mfgr Received | 2008-09-02 |
| Date Added to Maude | 2009-03-03 |
| 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, MANAGER |
| 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. 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 | BITE-GARD MOLAR BITE BLOCK |
| Generic Name | BITE GARD |
| Product Code | JXL |
| Date Received | 2008-09-29 |
| Returned To Mfg | 2008-09-12 |
| Model Number | NA |
| Catalog Number | 1140 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-29 |