MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-09-10 for BURR, OVAL, 8 FLUTE 4.0MM X 13CM AR-8400OBE manufactured by Arthrex, Inc..
| Report Number | 1220246-2019-01305 |
| MDR Report Key | 8980908 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-09-10 |
| Date of Report | 2019-09-10 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2019-09-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURR, OVAL, 8 FLUTE 4.0MM X 13CM |
| Generic Name | BURR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GFF |
| Date Received | 2019-09-10 |
| Model Number | BURR, OVAL, 8 FLUTE 4.0MM X 13CM |
| Catalog Number | AR-8400OBE |
| Lot Number | 10293299 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-10 |