MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-21 for SIR-SPHERES? Y-90 RESIN MICROSPHERES manufactured by Sirtex Technology Pty Ltd.
| Report Number | 3005579300-2020-00002 |
| MDR Report Key | 9738549 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-02-21 |
| 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 Street | SHOP 6 207 PACIFIC HIGHWAY |
| Manufacturer City | ST LEONARDS, 2065 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIR-SPHERES? Y-90 RESIN MICROSPHERES |
| Generic Name | MICEOSPHERES |
| Product Code | NAW |
| Date Received | 2020-02-21 |
| Lot Number | NI403V09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRTEX TECHNOLOGY PTY LTD |
| Manufacturer Address | SHOP 6 207 PACIFIC HIGHWAY ST LEONARDS, 2065 AS 2065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2020-02-21 |