Brand Name | SIR-SPHERES MICROSPHERES |
Type of Device | YTTRIUM 90 RESIN MICROSPHERES |
Manufacturer (Section D) |
SIRTEX MEDICAL LIMITED |
level 33 |
101 miller street |
north sydney, nsw 2060 |
AS 2060 |
|
Manufacturer (Section G) |
SIRTEX WILMINGTON LLC |
16 upon drive, unit 2-4 |
|
wilmington MA 01887 |
|
Manufacturer Contact |
rachel
tserng
|
level 33 |
101 miller street |
north sydney, nsw 2060
|
AS
2060
|
|
MDR Report Key | 8276507 |
MDR Text Key | 134060318 |
Report Number | 9710358-2019-00001 |
Device Sequence Number | 1 |
Product Code |
NAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P99065 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/03/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | SIR-Y001 |
Device Catalogue Number | SIR-Y001 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/03/2019 |
Initial Date FDA Received | 01/24/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|