Brand Name | ILAB ULTRASOUND IMAGING SYSTEM |
Type of Device | CATHETER, ULTRASOUND, INTRAVASCULAR |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
EP TECHNOLOGIES, INC. |
150 baytech drive |
|
san jose CA 95134 |
|
Manufacturer Contact |
sonali
arangil
|
two scimed place |
maple grove, MN 55311
|
6515827403
|
|
MDR Report Key | 7886036 |
MDR Text Key | 120577079 |
Report Number | 2134265-2018-61068 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 08714729761235 |
UDI-Public | 08714729761235 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K151613 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/18/2018 |
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
|
Device Model Number | 8864 |
Device Catalogue Number | 8864 |
Device Lot Number | 0000007420 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/23/2018 |
Initial Date FDA Received | 09/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/09/2011 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |