Brand Name | POD |
Type of Device | DEVICE, NEUROVASCULAR EMBOLIZATION |
Manufacturer (Section D) |
PENUMBRA, INC. |
one penumbra place |
alameda CA 94502 |
|
MDR Report Key | 6759621 |
MDR Text Key | 81601489 |
Report Number | 6759621 |
Device Sequence Number | 1 |
Product Code |
HCG
|
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 |
Other
|
Type of Report
| Initial |
Report Date |
07/31/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Model Number | RBYPODJ60 |
Device Catalogue Number | RBYPODJ60 |
Device Lot Number | F76859 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/31/2017 |
Event Location |
Other
|
Date Report to Manufacturer | 07/31/2017 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/02/2017 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 21 YR |
|
|