MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for 4.5MM FULL RADIUS PLATINUM SERIES 72203521 manufactured by Smith & Nephew, Inc..
| Report Number | 1219602-2019-01509 |
| MDR Report Key | 9391825 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2019-01-06 |
| Date Added to Maude | 2019-11-29 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM FULL RADIUS PLATINUM SERIES |
| Generic Name | SAW, POWERED, AND ACCESSORIES |
| Product Code | HAB |
| Date Received | 2019-11-29 |
| Catalog Number | 72203521 |
| Lot Number | 50779839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-29 |