Brand Name | ANGIODYNAMICS SOLERO MW PROBE |
Type of Device | SOLERO PROBE MICROWAVE TISSUE ABLATION APPLICATOR |
Manufacturer (Section D) |
ANGIODYNAMICS, INC. |
14 plaza drive |
|
|
MDR Report Key | 14021152 |
MDR Text Key | 288691875 |
Report Number | 14021152 |
Device Sequence Number | 1 |
Product Code |
NEY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/01/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/06/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/16/2022 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/01/2022 |
Distributor Facility Aware Date | 03/03/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/01/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 60 YR |
Patient Sex | Male |
Patient Weight | 68 KG |
Patient Race | White |
|
|