Brand Name | SIR-SPHERES MICROPSHERES |
Type of Device | YTTRIUM 90 RESIN MICROSPHERES |
Manufacturer (Section D) |
SIRTEX MEDICAL LIMITED |
level 33 |
101 miller st |
north sydney, nsw 2060 |
AS 2060 |
|
Manufacturer (Section G) |
SIRTEX WILMINGTON LLC |
unit 2-4, 16 upton drive |
|
wilmington MA 01887 |
|
Manufacturer Contact |
grant
spindler
|
level 22, 101 miller st |
north sydney, nsw 2060
|
AS
2060
|
|
MDR Report Key | 7875700 |
MDR Text Key | 120241393 |
Report Number | 9710358-2018-00001 |
Device Sequence Number | 1 |
Product Code |
NAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P990065 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/09/2018 |
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 |
02/21/2018 |
Initial Date FDA Received | 09/13/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|