MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for ARTHREX BURR, OVAL, 8 FLUTE 4.0 MM AR-8400OBE manufactured by Arthrex, Inc..
| Report Number | MW5090373 |
| MDR Report Key | 9192786 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-09-30 |
| Date Added to Maude | 2019-10-15 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTHREX BURR, OVAL, 8 FLUTE 4.0 MM |
| Generic Name | BUR, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GFF |
| Date Received | 2019-10-11 |
| Returned To Mfg | 2019-09-30 |
| Model Number | AR-8400OBE |
| Catalog Number | AR-8400OBE |
| Lot Number | 10306067 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |