Brand Name | THERASPHERE Y-90 (6 GBQ) |
Type of Device | MICROSPHERES RADIONUCLIDE |
Manufacturer (Section D) |
BIOCOMPATIBLES UK LIMITED |
weydon lane, farnham |
surrey GU9 8 QL |
UK GU9 8QL |
|
Manufacturer (Section G) |
BIOCOMPATIBLES UK LIMITED |
weydon lane, farnham |
|
surrey |
UK
|
|
Manufacturer Contact |
jay
johnson
|
4100 hamline ave n |
arden hills, MN 55112
|
6515810888
|
|
MDR Report Key | 15904368 |
MDR Text Key | 304684546 |
Report Number | 2124215-2022-47163 |
Device Sequence Number | 1 |
Product Code |
NAW
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | H980006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/02/2022 |
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 |
Health Professional
|
Device Model Number | 2361-03 |
Device Catalogue Number | 2361-03 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/10/2022 |
Initial Date FDA Received | 12/02/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|