Brand Name | TARGET HELICAL NANO 1MM X 2CM |
Type of Device | DEVICE, NEUROVASCULAR EMBOLIZATION |
Manufacturer (Section D) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
|
Manufacturer (Section G) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
|
Manufacturer Contact |
sanda
dracic
|
47900 bayside parkway |
fremont, CA 94538
|
5104132500
|
|
MDR Report Key | 5903920 |
MDR Text Key | 52988754 |
Report Number | 3008881809-2016-00145 |
Device Sequence Number | 1 |
Product Code |
HCG
|
Combination Product (y/n) | N |
Reporter Country Code | KR |
PMA/PMN Number | K113412 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/28/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/25/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | M0035431020 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/28/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |