MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-07 for BITEGARD * 1140 manufactured by Hudson Rci/teleflex Medical.
| Report Number | 2446098 |
| MDR Report Key | 2446098 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-02-07 |
| Date of Event | 2012-02-05 |
| Report Date | 2012-02-07 |
| Date Reported to FDA | 2012-02-07 |
| Date Added to Maude | 2012-02-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITEGARD |
| Generic Name | BITE BLOCK |
| Product Code | BRW |
| Date Received | 2012-02-07 |
| Model Number | * |
| Catalog Number | 1140 |
| Lot Number | 01935 OR 02J1001825 |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUDSON RCI/TELEFLEX MEDICAL |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-07 | |
| 2 | 0 | 2012-02-07 | |
| 3 | 0 | 2012-02-07 |