MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-03 for SIR SPHERES Y-90 MICROSPHERES SIR-Y001 manufactured by Sirtex Wilmington Llc.
| Report Number | 3005579300-2019-00007 |
| MDR Report Key | 9270716 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-03 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2019-11-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RACHEL TSERNG |
| Manufacturer Street | 300 UNICORN PARK DR. |
| Manufacturer City | WOBURN MA 01801 |
| Manufacturer Country | US |
| Manufacturer Postal | 01801 |
| Manufacturer G1 | SIRTEX WILMINGTON LLC |
| Manufacturer Street | 16 UPON DR. NO. 2-4 |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIR SPHERES Y-90 MICROSPHERES |
| Generic Name | YTTRIUM-90 RESIN MICROSPHERES |
| Product Code | NAW |
| Date Received | 2019-11-03 |
| Model Number | SIR-Y001 |
| Catalog Number | SIR-Y001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRTEX WILMINGTON LLC |
| Manufacturer Address | 16 UPON DR. NO. 2-4 WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-03 |