Type of Device | INJECTOR, CONTRAST MEDIUM, AUTOMATIC |
MDR Report Key | 15454597 |
MDR Text Key | 300225474 |
Report Number | 15454597 |
Device Sequence Number | 1 |
Product Code |
IZQ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/07/2022,09/06/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/20/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/07/2022 |
Date Report to Manufacturer | 09/20/2022 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 27010 DA |
Patient Sex | Female |
|
|