MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-08 for BAR DENTAL ARCH, STAINLESS STEEL, 5" LENGTH RH 2715 manufactured by V. Mueller Div. Baxter Healthcare Corp..
[20474753]
Pt was involved in a mva and had arch bars placed for a mandible fracture. Mandible fracture was diagnosed as well healed and the pt elected to have the arch bars removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006635 |
| MDR Report Key | 24170 |
| Date Received | 1995-08-08 |
| Date of Report | 1995-08-01 |
| Date of Event | 1995-06-27 |
| Date Added to Maude | 1995-08-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAR DENTAL ARCH, STAINLESS STEEL, 5" LENGTH |
| Generic Name | ARCH BARS |
| Product Code | EHO |
| Date Received | 1995-08-08 |
| Catalog Number | RH 2715 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 24527 |
| Manufacturer | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
| Manufacturer Address | MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-08-08 |