Brand Name | ASCULEP |
Type of Device | RONGEUR, MANUAL |
MDR Report Key | 9659241 |
MDR Text Key | 177377431 |
Report Number | 9659241 |
Device Sequence Number | 1 |
Product Code |
HAE
|
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 |
01/24/2020 |
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 |
Health Professional
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/24/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/03/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/03/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|