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.
[20198218]
The event was reported as: white handle broke off the green bite block at the time the bit-gard was being removed from the patient's mouth. It did not go down the patient's throat. Required removal with forceps. No patient injury reported. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[20551005]
Sample is not available for investigation. Evaluation report not available at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2008-00061 |
| MDR Report Key | 1204673 |
| Report Source | 08 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-10-03 |
| Date Mfgr Received | 2008-10-03 |
| Date Added to Maude | 2009-06-29 |
| 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 - NUEVO LAREDO |
| 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 |
| 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 | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2008-10-20 |