Type of Device | CATHETER, IRRIGATION |
MDR Report Key | 10657047 |
MDR Text Key | 211539570 |
Report Number | 10657047 |
Device Sequence Number | 1 |
Product Code |
GBX
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/10/2020 |
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 |
No Information
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/10/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/09/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/09/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 29565 DA |
|
|