MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-31 for BITEGARD manufactured by Teleflex Medical - Hudson Rci -.
[16582787]
Bitegard separated in pt's mouth requiring removal with forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022925 |
| MDR Report Key | 2324763 |
| Date Received | 2011-10-31 |
| Date of Report | 2011-10-31 |
| Date of Event | 2011-10-09 |
| Date Added to Maude | 2011-11-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITEGARD |
| Generic Name | ORAL BITE BLOCK |
| Product Code | JXL |
| Date Received | 2011-10-31 |
| Returned To Mfg | 2011-10-18 |
| ID Number | REF 1140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL - HUDSON RCI - |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-31 |