Brand Name | SOFIA 5F-125CM STR |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
MICROVENTION INC. |
1311 valencia avenue |
tustin CA 92780 |
|
MDR Report Key | 9557352 |
MDR Text Key | 173923687 |
Report Number | 9557352 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/30/2019,12/27/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | DA5125ST |
Device Catalogue Number | DA5125ST |
Device Lot Number | 190903138 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/30/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/07/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/07/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 19345 DA |
Patient Weight | 106 |
|
|